The new Accu-Chek Compact Plus

Transcription

ACCU-CHEK
®
Compact Plus
BLOOD GLUCOSE MONITORING SYSTEM
Reference Manual
On the packaging, on the type plate of the meter and on the finger
pricker you may encounter the following symbols shown below. They
have the following meanings:
Consult instructions for use
Caution (refer to accompanying documents). Please refer to
safety-related notes in the instructions for use accompanying this instrument.
The explanation of any other symbols can be found in the instructions/
inserts, accompanying components within the packaging.
Store at
Use by / Expiry date
For single use only
Sterilized through irradiation
Manufacturer
Catalogue number
Lot number
IVD
For in vitro diagnostic use
0088 Blood glucose meter: This product fulfils the requirements
of Directive 98/79/EC on in vitro diagnostic medical
devices.
Finger pricker and lancets: These products fulfil the
requirements of Directive 93/42/EEC on medical devices.
Last update: 2008-07
3
Intended use
Accu-Chek Compact Plus Blood Glucose Meter
Accu-Chek Softclix Plus Finger pricker
Meter for quantitative determination of blood glucose values in fresh
capillary blood using Accu-Chek Compact test strips.
Finger pricker with adjustable depth setting for obtaining capillary blood
from a fingertip or earlobe and, when a special AST cap is used, from
alternative sites such as the ball of the thumb.
Suitable for self-testing.
The meter may be used by people with diabetes to test their own blood
glucose as well as for blood glucose determination by healthcare practitioners in a professional setting.
The Accu-Chek Softclix Plus finger pricker is intended only for
patient self-monitoring by a single person. It must not be used
to collect blood in a multi-patient setting as it does not
incorporate any features to guard against cross-infections.
Healthcare professionals must observe additionally the directions
in Chapter 10 “Blood glucose testing in a multi-patient setting –
Information for healthcare professionals”.
The Accu-Chek Softclix Plus finger pricker is intended for patient
self-monitoring by a single person.
It must not be used to collect blood in a multi-patient setting as it
does not incorporate any features to guard against cross-infection.
Any object coming into contact with human blood is a potential
source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline – Third Edition; CLSI
document M29-A3, 2005).
4
Intended use
Intended use
5
About this Reference Manual
Please read this Reference Manual carefully and completely before
testing blood glucose for the first time. If you have any questions, please
contact your local customer support and service centre (see Chapter
17).
Other symbols are used, too. They have the following meaning:
This Reference Manual will help you get to know your meter and finger
pricker step by step. It will provide you with all the information you need
to operate and care for your meter and finger pricker and to deal with
any errors that might occur. Remember that, in order to keep your meter
and finger pricker in good working condition, you need to follow the correct operating procedures and also observe certain other instructions.
The meter and finger pricker are precision instruments and improper
handling can impair their operation.
" This symbol signifies a list.
This symbol is a prompt for you to do something, such as turn the
meter on.
This symbol signifies a list within a list.
We recommend that you start by getting to know all of the features of
your meter and finger pricker (see Chapter 1.1 and 1.2). Try out all of
the steps described in this manual, and also practise using the meter
and finger pricker.
Should you have any questions, please call the Accu-Chek Customer
Careline free on 0800 701000 (UK) or 1800 709600 (Ireland).
This Reference Manual features three symbols to draw your attention to
important information. Please read these points with special care.
This symbol indicates a possible risk of injury or of damage to
your own health or to the health of others.
This symbol draws attention to actions that could result in damage to meter or to the finger pricker.
i
6
This symbol draws your attention to important information.
7
Contents
1
Introduction ................................................................................ 12
1.1 The Accu-Chek Compact Plus blood glucose meter at
a glance .............................................................................. 12
1.2 The Accu-Chek Softclix Plus finger pricker at a glance ........ 15
1.3 Main features...................................................................... 16
1.4 Display illustrations ............................................................. 19
2
Initial steps before testing......................................................... 20
2.1 Checking the contents ........................................................ 20
2.2 Checking the blood glucose unit.......................................... 20
2.2.1 Type plate ............................................................... 21
2.2.2 Display check.......................................................... 21
2.3 Inserting or replacing the test strip drum ............................. 24
2.3.1 Test strip drum use-by period.................................. 33
2.3.2 Indication of the number of test strips remaining ..... 36
3
Settings ...................................................................................... 38
3.1 Changing settings – General rules ....................................... 41
3.2 Turning the meter on ........................................................... 44
3.3 Setting the beep tone or Acoustic Mode .............................. 45
3.4 Setting the brightness of the display ................................... 48
3.5 Setting the year................................................................... 50
3.6 Setting the time/date format ............................................... 52
3.7 Setting the time .................................................................. 54
3.8 Setting the date .................................................................. 56
3.9 Setting the alarm clock function .......................................... 59
3.10 Setting the hypo indicator ................................................... 67
8
Contents
4
Testing blood glucose ................................................................ 70
4.1 Preparing to test blood glucose ........................................... 70
4.2 Preparing the finger pricker................................................. 70
4.2.1 Undocking the finger pricker from the meter ........... 73
4.2.2 Docking the finger pricker onto the meter ............... 74
4.2.3 Inserting the lancet ................................................. 75
4.3 Testing blood glucose.......................................................... 78
4.3.1 Turning the meter on ............................................... 78
4.3.2 Obtaining blood ....................................................... 80
4.3.3 Drawing up blood with the test strip ........................ 84
4.4 Ejecting the test strip .......................................................... 90
4.5 Ejecting the used lancet ...................................................... 92
4.6 Symbols you see before, during or after testing and
what they mean .................................................................. 95
4.7 Flagging special results....................................................... 96
4.8 Evaluating results................................................................ 97
4.8.1 Measuring range ..................................................... 98
4.8.2 Implausible results – possible causes of error ......... 99
5
Using the meter as an electronic notebook ............................ 101
5.1 Memory ............................................................................ 101
5.2 Retrieving results from memory ........................................ 102
5.3 Average, highest value and lowest value for 7, 14
and 30 days ...................................................................... 107
5.4 Downloading test results to a PC, handheld computer
or a special evaluation system .......................................... 114
Contents
9
6
Acoustic Mode.......................................................................... 120
6.1 Beep tones at power-on .................................................... 122
6.2 Beep tones during testing ................................................. 123
6.3 Announcement of the result following a test ...................... 123
6.4 Announcement of results and average values from
memory ............................................................................ 126
6.5 Announcement of warnings and error messages ............... 128
7
Checking your meter................................................................ 129
7.1 What you need .................................................................. 130
7.2 Performing a performance check ...................................... 131
7.3 Possible causes of error during the performance of
performance checks ......................................................... 137
8
Cleaning the meter and finger pricker .................................... 140
8.1 Cleaning the meter............................................................ 140
8.2 Cleaning the finger pricker ................................................ 144
9
Changing the batteries ............................................................ 145
10 Blood glucose testing in a multi-patient setting –
Information for healthcare professionals ............................... 150
10.1 Replacing the finger pricker with a blanking plate ............. 152
10.2 Testing blood glucose........................................................ 154
10.3 Disinfecting the meter ....................................................... 158
10.4 Suitable disinfectants ........................................................ 162
10
Contents
11 Measurement and storage conditions .................................... 163
11.1 Temperature range............................................................ 163
11.2 Light conditions ................................................................ 165
11.3 Humidity ........................................................................... 166
11.4 Local sources of interference ............................................ 166
12 Symbols, error messages and troubleshooting ...................... 167
12.1 Symbols shown in the display ........................................... 168
12.1.1 Single symbols ...................................................... 170
12.1.2 Combinations of symbols ...................................... 176
12.1.3 Symbols appearing in the numeric field ................. 179
12.2 Interferences and error messages – causes and
troubleshooting recommendations .................................... 181
13 Technical data .......................................................................... 196
14 Disposing of the meter............................................................. 200
15 System components ................................................................ 201
16 Patents...................................................................................... 202
17 Local customer support and service ....................................... 203
17.1 Advice and troubleshooting ............................................... 203
17.2 Addresses ......................................................................... 204
18 Alphabetical index ................................................................... 205
Contents
11
1
1
Introduction
The meter is supplied with batteries already inserted. The time and date
are already set. You may need to adjust these settings to your own time
zone (see Chapter 3).
/ Display window
0 S button
Press this button to change settings.
1 Recess for docking the finger pricker
1.1
The Accu-Chek Compact Plus blood glucose meter at a
glance
Front
/
:
0
9
1
2
3
8
2 Test button
Use this button only if you want to test your blood glucose or perform a performance check, or wish to turn the meter off. Pull the
button downwards towards the drum compartment cover. The button tips downwards and the meter turns on. This pull-tip mechanism
stops the meter from turning on inadvertently.
3 Drum compartment
4 Drum release button
5 Test strip guide
6 Measuring window
7 Test strip
8 Test strip drum
9 Drum compartment cover*
7
4
6
5
: M Button
Press this button to retrieve results stored in the meter’s memory.
Tip of the test strip – where
blood is drawn up
* available as replacement part
12
Introduction
Introduction
13
1
1.2
Back
B
;
A
The Accu-Chek Softclix Plus finger pricker at a glance
D
C
@
u
<
B
=
A
v
w
>
z
x
?
; Battery compartment cover*
< Infrared window for sending
results to a PC, for instance
= Batteries: type AAA, LR 03,
AM 4, Micro
@ Control window (shows the
number of strips remaining)
A Finger pricker*
B Slide button for undocking the
finger pricker
> Battery compartment
y
u Plunger
The plunger is a multifunction
button used to prime, trigger
and eject the lancet.
v Window showing the penetration depth setting
w Lancet holder
? Type plate
x Lancet
z Pin-hole opening for lancet
A Cap
B Comfort Dial for depth selection (you change the depth by
rotating the cap)
C Locating notch
D Locating line
y Protective cap on lancet
* available as replacement part
14
Introduction
Introduction
15
1
1.3
Main features
Docked finger pricker
The meter comes with an attached Accu-Chek Softclix Plus finger
pricker. You can leave it docked onto the meter to collect blood or, if you
prefer, you can undock it.
Test strip drum instead of individual test strips
You never need to touch a test strip. Simply insert a drum with 17 test
strips into the meter.
Easy to operate
Turn the meter on, apply blood, read the result, press the button to eject
the test strip.
Automatic-coding
Every test strip drum has its own bar code. The meter is automatically
coded whenever you insert a new drum, a process which provides the
meter with information on the specific characteristics of the test strips.
Indication of the number of test strips remaining
Each time you turn the meter off, it shows you the number of test strips
remaining in the drum.
16
Introduction
Reliability
The meter checks each test strip. If it finds a defective strip, it lets you
know before you apply blood.
Blood volume checking
The meter can tell when you have applied sufficient blood (approximately 1.5 μL (1 microlitre = 1 thousandth of a millilitre)). It waits until
then before starting the test. If the test does not start, you may apply
more blood.
Alarm clock function
The meter can remind you to test your blood glucose. You can set an
acoustic signal to remind you at three different times.
Hypo indicator function
In order to look out for unusually low results you can set a hypo indicator level (hypo threshold). If a result is below the level you have set, a
symbol in the display and an acoustic signal (provided it is set to on)
prompt you to check your result carefully to see if you are heading
towards a possible hypo (low blood glucose).
Downloading data to a computer
The meter has an infrared window. You can download results to a computer running the appropriate software or to special analysis systems.
Introduction
17
1
Acoustic Mode
1.4
Acoustic Mode is intended for persons who are visually impaired. When
Acoustic Mode is turned on, the meter guides the user through the blood
glucose test using beep tones; it also outputs the result as a series of
beeps. For more information see Chapter 6.
Throughout this Reference Manual you will see examples of what the
display looks like. Any elements that are shown surrounded by a halo in
these examples flash in the display.
Visually impaired persons need a sighted person to instruct them
in the use of the meter and to assist them with all aspects of its
operation. Visually impaired persons must not test their blood
glucose without assistance from a sighted person.
Display illustrations
Example:
You have turned on the meter to perform a blood glucose test. In the
display you see the time and date plus the test strip symbol and the
drop symbol. The test strip symbol and drop symbol are flashing.
The time, date and blood glucose results shown in the display illustrations are intended only as examples. The numbers will not necessarily
be the same as those shown by your own meter. The meter that is used
for illustration in this manual displays blood glucose results in mmol/L
(see Chapter 2.2) and has been set to 24-hour format (see Chapter 3.6).
Your meter, on the other hand, may show blood glucose test results in
mg/dL and/or be set to 12-hour format.
18
Introduction
Introduction
19
2
Initial steps before testing
2.1
Checking the contents
2
2.2.1 Type plate
Check that your monitoring kit is complete. The package contents are
listed on the box.
The type plate on the back of your meter indicates which unit of measurement your meter uses.
If anything is missing, please contact the Accu-Chek Customer Careline
free on 0800 701000 (UK) or 1800 709600 (Ireland).
2.2.2 Display check
2.2
You can check the unit of measurement your meter uses by performing
a display check.
Checking the blood glucose unit
Blood glucose results can be displayed in two different units of measurement (mmol/L or mg/dL). Consequently, Roche sells two different
versions of the same meter. If you do not know which is the right unit for
you, ask your doctor. The unit of measure normally used in the UK and
Ireland is mmol/L.
Press and hold down the M button.
The meter turns on. While you hold down the M button, you first see the
display check.
mmol/L meter
or
mg/dL meter
Check that your meter displays the unit that is right for you.
Check the unit by referring to the type plate and to the display window
during a display check (see the following pages).
Note
The unit that your meter displays cannot be changed. If the
wrong unit is printed on the type plate, please consult your dealer
or pharmacy. Using the wrong unit can cause you to misinterpret
the test results.
20
The unit of measurement is shown in the bottom right corner of the display.
21
2
If you continue to hold down the M button, you then see the following
display after approximately 2 seconds.
mmol/L meter
mg/dL meter
Notes
i
If additional lines appear during the display test or parts of the
numeric field or of a symbol are missing, please contact the
Accu-Chek Customer Careline free on 0800 701000 (UK) or
1800 709600 (Ireland). If the numeric field (mmol/L meter)
or (mg/dL meter) is affected, the meter may not show your
test results correctly.
i
The meter automatically turns off after 60 seconds even if you
keep the M button pressed.
i
You can perform a display check whenever you wish. If there are
results already saved in memory, the most recently saved result
is displayed when you release the M button.
or
When you release the M button, your meter is in memory mode. As long
as no results have yet been saved, three bars are displayed.
Press the Test button to turn the meter off.
22
23
2
2.3
Inserting or replacing the test strip drum
If your meter is brand new and unused, it will contain a mock drum (an
empty drum without a label), which you must remove and replace with a
test strip drum.
Read the package insert that came with the test strip drums.
If the meter is on, press the Test button to turn it off.
Wait for the motor to stop.
Set into the bottom of the meter to the left of the finger pricker is a
recess. The upper part of this recess belongs to the drum compartment
cover.
Hold the meter in your right hand and place the thumb of your left
hand into this recess. Then pull the drum compartment cover with
your fingers slightly to the front and lift it up.
Drum compartment cover
Irrespective of whether a test strip drum is inserted or not:
Recess
Press the red drum release button.
24
25
2
The pin holding the test strip drum in position retracts with an audible
CLICK.
Insert a new test strip drum in the meter as illustrated (the two rows
of bar code must be nearest the display window).
Close the drum compartment cover and push it shut. There will be
an audible CLICK.
The meter turns on and rotates the test strip drum until the first test
strip is in the correct position. At the same time the meter reads the bar
code that provides it with information on the specific characteristics of
the test strips. After that, the meter turns off.
If there is a test strip drum in the meter:
Tip the meter forwards.
The test strip drum drops out.
26
27
2
A dot appears in the small control window on the back of the meter. This
indicates that you have just inserted a test strip drum. When you perform a blood glucose test, the meter counts the number of test strips
that you have used. The number of strips remaining is displayed in the
control window.
If you do not insert a new drum, the following message appears the next
time you turn on the meter:
H> and the drum symbol are flashing to indicate that the test strip
drum is empty.
Notes
When all the test strips in a drum have been used up, the dot reappears
in the small control window.
Use only test strips that are not beyond their expiry date.Test
strips that have expired can produce incorrect results. Incorrect
results can cause the wrong therapeutic decision to be taken and
so produce serious adverse health effects. The expiry date is
printed on the pack and on the peel-off label on the drum container next to the symbol.
Insert a new test strip drum.
28
29
2
New test strip drums where the aluminium foil (the silver ends) is
damaged cannot be used. Your blood glucose results may be
incorrect if you use a damaged drum. Incorrect results can cause
the wrong therapeutic decision to be taken and so produce
adverse health effects.
Only open the drum compartment cover when the meter is turned
off and the motor is not running. Opening the drum compartment
cover when the meter is turned on may result in damage to the
meter.
i
Handle the test strip drums with care! Only remove a test strip
drum from its container when you intend to use it. The container
protects the aluminium foil on the drum from damage.
i
There is a label on every drum container. The left portion may be
peeled off. On it is the concentration table for the Accu-Chek
Compact Autocontrol control solutions. The stated concentrations
are valid only for the test strips contained in this drum. You need
this table for the performance check of your meter (see Chapter
7). You may, for instance, wish to stick the peel-off label in your
notebook or diary. When conducting a performance check,
always check that the peel-off label with the concentration table
belongs to the test strip drum that is currently in the meter.
30
i
If you insert a partly used drum in the meter, the meter rotates
the drum so the dot appears in the control window on the back.
When you subsequently turn on the meter to perform a test
and ...
" ... you have re-inserted a same drum you previously
removed:
The meter immediately rotates the drum to the first chamber
that contains a test strip, and ejects the strip.
" ... you have used up the previous drum or have replaced one
partly used drum with another partly used one:
The meter may search all chambers until it finds the first one
that contains a test strip. The fewer test strips the drum contains, the longer the process takes.
If the meter immediately rotates the drum to one of the
chambers near the end (you can tell by the noise of the motor
that rotates the drum), the drum may ultimately still contain
test strips even though the meter regards it as empty. You can
still use the test strips by inserting the drum again.
31
2
If you insert a partly used test strip drum into the meter, the
meter cannot calculate the use-by period for that drum. Consequently, the next time you perform a test, the drum symbol and
flashing bottle symbol are displayed to highlight the fact (see
Chapter 2.3.1).
2.3.1 Test strip drum use-by period
i
Use only Accu-Chek Compact test strip drums. Other test strips
cannot be used to perform tests. If you insert a different test strip
drum, error message E22 is displayed (see Chapter 12.2).
Once a drum has been in the meter for 90 days, its use-by period has
expired. The next time you turn the meter on to perform a test, the drum
symbol, bottle symbol and clock symbol are displayed to highlight the
fact.
i
Make sure that the drum compartment cover is tightly closed. If it
is not properly closed, the meter will not turn on when you press
the Test button. All you see is the display check briefly.
i
You can dispose of used test strip drums with your regular
household waste.
i
When you insert a new drum into the meter, the meter starts to count
the number of days the drum is in the meter. Each drum must be used
within a 90-day use-by period.
Note
The test strips in this drum cannot be used. You must not use
these test strips as they may produce incorrect results. Incorrect
results can cause the wrong therapeutic decision to be taken and
so produce serious adverse health effects.
32
33
2
The meter is unable to calculate the 90-day use-by period if
" you insert a partly used drum in the meter, even if it is the same one
you have just removed,
" Flashing test strip and flashing drop, indicating that you may now
apply blood or control solution
" Drum, indicating that the use-by period cannot be calculated
" the year, date and time settings are lost when you replace the batteries (see Chapter 9), and a partly used drum remains in the meter.
" Flashing bottle, prompting you to perform a performance check in
order to check the test strips
The meter has no way of telling you in these cases when the drum was
first inserted or how long the partly used drum has already been in the
meter.
Perform a performance check (see Chapter 7).
If the meter cannot calculate the use-by period and you turn the meter
on to perform a test, the following symbols appear in the display:
If the result from the performance check is within the stated concentration range, you can still use the test strips remaining in the drum. If the
result is outside the range, you need to insert a new drum.
Following the performance check, the bottle symbol disappears from the
display. If you do not perform a performance check, the flashing bottle
symbol appears with every test until you insert a new drum. The drum
symbol continues to be displayed with each test in order to draw your
attention to the fact that the meter cannot calculate the use-by period.
All results are saved along with the drum symbol. The drum symbol only
disappears when you insert a new drum.
34
35
2
2.3.2 Indication of the number of test strips remaining
Each time you turn the meter off with the Test button, it shows you the
number of test strips remaining in the drum. The number of remaining
strips continues to be displayed as long as you hold down the Test
button.
In this example there are still 12 test strips in the drum.
i
If you have not performed a test since last replacing the drum,
the meter cannot tell how many test strips there are left in the
drum. This is e.g. the case when, after you have changed the
drum, you start by changing settings or retrieve results from
memory. If you then press the Test button to turn the meter off,
only three horizontal bars
are displayed instead of the
number of test strips remaining. Only when you have performed
a test with the newly inserted drum does the meter display the
number of test strips remaining each time you turn the meter off
with the Test button.
When you release the Test button, the meter turns off.
Notes
i
If the test strip drum contains three or fewer test strips following
a test, the number, the test strip symbol and drum symbol flash in
the display window.
i
If you press the Test button only briefly when turning the meter
off, the number of test strips remaining is displayed only briefly
or not at all.
36
37
3
Settings
You can change the settings of your meter to turn the beep tone or
Acoustic Mode on or off, to set the brightness of the display, to select
the time-and-date format, to set the year, the time and the date, and to
activate the alarm clock function and the hypo indicator.
When you turn the meter on for the first time, it has the following presettings. These are factory defaults that you can change.
" Beep tone on, Acoustic Mode off
" Brightness of the display: medium
Beep tone: When the beep tone is set to on, it provides user support
during testing by marking the start of each step acoustically.
Acoustic Mode: When Acoustic Mode is turned on, the meter guides
you through the blood glucose test using beep tones; it also outputs the
result as a series of beeps.
" Year: current year, e.g. 2007
" Time-and-date format: 24-hour format;
24-hour format is associated with the date format day-month
(DD-MM)
" Time: current time based on Central European Time
Alarm clock function: You can set the meter to remind you to test your
blood glucose.
" Date: current date based on Central European Time
Hypo indicator: You can set a personal hypo indicator level. If your
result is below this level, the meter alerts you to the fact that you are
possibly heading towards a hypo.
" Hypo indicator off
The meter is supplied with batteries already inserted. The time and date
are already set. You may need to adjust these settings to your own time
zone.
" Alarm clock function off
Notes
i
You can perform blood glucose tests without adjusting any of the settings. All settings are the default factory settings (see next page).
38
Settings
Settings
If the year, time and date settings were lost as a result of a battery replacement (see Chapter 9) and you fail to reset these, the
meter displays the time as 0:00 and the date as 0-00 (in 24-hour
format as well as in 12-hour format) when you perform a test.
In memory the results are saved not with the time and date but
with their memory location number (see Chapter 5.2). Without the
time and date the meter is not able to calculate averages, nor the
lowest and the highest values (see Chapter 5.3). Results sent to a
39
3
PC, for instance, without the time and date (see Chapter 5.4) cannot be statistically analyzed or, if they can, then only to a limited
extent.
i
The descriptions of settings proceed in the order in which they appear in
the meter.
If the year, date and time settings are lost as a result of a battery
replacement, the meter displays the following settings:
Beep tone or
Acoustic Mode
Brightness
of the display
Year
Time-and-date
format
Time
Date
Alarm clock
function
Hypo indicator
" Year: year of manufacture 20XX, e.g. 2007
" Time: 0:00 or 12:00 a.m., depending on the time-and-date
format you selected previously
" Date: 1-01 as day-month (D-MM) or month-day (M-DD),
depending on the time-and-date format you selected previously
3.1
Changing settings – General rules
The appearance of
in the display window indicates that the meter
is in settings mode and that you can change these.
In the sections set out below you will find
" a description of the general rules for changing settings,
" descriptions of individual settings and how to change them.
40
Settings
Settings
41
3
The procedure for changing the settings is as follows:
" The settings have a fixed sequence and are displayed consecutively,
see illustration on the previous page.
" Press the S button to call up the settings.
A test strip is not advanced.
" Press the M button to change the setting that is currently flashing.
Numbers such as the year are incremented by one. Pressing and
holding down the button increments the number quickly.
" From the last setting “Hypo indicator” pressing the S button takes
you back to the first setting “Beep tone/Acoustic Mode”.
" You can close the settings at any time by pressing the Test button.
All settings you have entered up to that point are saved.
Notes
i
Always turn the meter on with the S button when you intend to
change the settings.
Instead, if you turn the meter on with the Test button and there is
a drum in the meter, a test strip will be advanced.
i
If you turn the meter off with the Test button, it shows you the
number of test strips remaining in the drum (see Chapter 2.3.2).
i
The meter turns off automatically after approximately 60 seconds
if you do not press a button. All settings you have confirmed up to
that point with the S button are retained. Settings that you have
not confirmed with the S button are lost and the original setting
remains.
From the highest selectable number, pressing the M button automatically takes you to the lowest one.
In the case of settings where there are a number of options, such
as the beep tone setting, pressing the M button presents each
option in turn.
" Press the S button to save the chosen setting and move on to the
next setting.
" You can change any setting at any time. Press the S button repeatedly until the setting you wish to change is displayed flashing.
42
Settings
Settings
43
3
3.2
Turning the meter on
3.3
3
Setting the beep tone or Acoustic Mode
You are here
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
24-hour / 12-hour
This setting enables you to turn the beep tone on or off and to activate
Acoustic Mode.
When the beep tone is turned on, you hear a beep during testing
With the meter turned off, press the S button.
" when the meter is ready to test so you can draw up blood or control
solution with the test strip,
The meter turns on without advancing a test strip.
Following the display check (see Chapter 2.2.2) the current beep tone
setting (symbol ) is flashing.
" when the test strip has drawn up sufficient blood or control solution
and test has started,
" when the result is displayed,
" when the hypo indicator is turned on and the result is below the
level you have set,
" when the meter displays an error message.
44
Settings
Settings
45
There are two types of beep tone, differing in pitch. The pitch for a hypo
indicator or an error message is higher than that heard in the other
cases listed above.
When Acoustic Mode is turned on, the meter guides you through the
blood glucose test using the beep tones mentioned above; it also
announces the result as a series of beeps (see Chapter 6).
The beep tone is factory-set to on (H).
Press the S button to save the chosen setting.
The brightness setting comes next.
Notes
i
When you select Acoustic Mode H, you hear a beep.
i
The beep tone setting has no influence on the alarm clock function. If you have turned the alarm clock function on (see Chapter
3.9), the meter will always beep to remind you to test your blood
glucose even if the beep tone itself is turned off.
Beep tone turned on
Beep tone turned off
46
3
Press the M button to move to the next option.
Acoustic Mode turned on
Settings
Settings
47
3.4
3
Medium brightness
(level )
Setting the brightness of the display
You are here
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
24-hour / 12-hour
You can use this setting to adjust how bright you wish the displayed
symbols and numbers to be. There are three brightness levels: low,
medium and high.
The brightness is factory-set to medium (shown by the at top right of
the display window).
Low brightness
(level )
High brightness
(level )
The brightness of the display window changes to the setting you have
selected.
The year setting comes next.
48
Settings
Settings
49
3.5
Setting the year
3
The time-and-date format setting comes next.
You are here
Notes
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
i
The year you have set is not displayed during testing, nor
together with the result, nor when you look at saved results in
memory. It is only displayed when you are in the settings. However, having the correct year setting is still important because
without it the meter will not be able to recognize February 29th in
a leap year. The correct year setting is also needed to unambiguously identify your blood glucose test results when you download
them to a computer for analysis or further processing.
i
The year can be set from the year of production to the year of
production plus 32.
24-hour / 12-hour
The year that is currently set flashes at top right of the display.
Press the M button repeatedly, or press and hold it down, until the
required year is displayed.
50
Settings
Settings
51
3.6
Setting the time/date format
You are here
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
The factory setting is 24-hour format (B).
Time-and-date
format
24-hour / 12-hour
You can choose between two formats. In 24-hour format the time is displayed from 0:00 to 23:59. If you select this format, the date is displayed in the format DD-MM (day-month, no year). In 12-hour format
the time is displayed from 12:00 to 11:59 with a.m. or p.m. If you
choose this format, the date format changes to MM-DD (month-day, no
year).
The time-and-date format is shown together with the current time and
the current date setting. If the format is changed, the way the time and
date are displayed also changes.
52
3
The time-and-date format that is currently set flashes in the display.
Settings
Press the M button to select 12-hour format.B is displayed.
If you press the M button again, B reappears and 24-hour format is
set.
The time setting comes next.
Settings
53
3.7
3
Setting the time
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
12-hour
format
24-hour / 12-hour
required hour is displayed.
The minute setting comes next.
You are here
The minutes flash at top left of the display.
The time and the date that are currently set are displayed.
The hour flashes at top left of the display.
24-hour
format
24-hour
format
12-hour
format
54
Settings
Settings
55
required minutes are displayed.
3
The month flashes at top right of the display.
24-hour format
(DD-MM)
The date setting comes next.
3.8
Setting the date
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
24-hour / 12-hour
12-hour format
(MM-DD)
required month is displayed.
You are here
56
The day setting comes next.
Settings
Settings
57
3.9
The day flashes at top right of the display.
24-hour format
(DD-MM)
3
Setting the alarm clock function
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
Year
Time-and-date
format
24-hour / 12-hour
12-hour format
(MM-DD)
You are here
You can use the meter’s alarm clock function to remind you to test your
blood glucose. You can set three alarms.
required day is displayed.
The alarm clock settings come next.
58
The meter beeps for 20 seconds at the appointed time every day. The
meter then turns off again. You can turn the beep tone off earlier. Do this
by pressing any of the three buttons. The meter then turns off. A test
strip is not advanced.
While it is beeping, the meter
displays the following:
Settings
Settings
59
Two steps are involved in entering the setting. First you define whether
the alarm clock function is basically to be turned on (H) or off ( ).
When it is on, you can enter or change the alarm times.
The alarm clock function (
the display.
symbol) is factory-set to off. If you have turned the alarm clock function on, the setting for the first
alarm time comes next. The following is displayed:
flashes in
24-hour format
12-hour format
If you have turned the alarm clock function off, the setting for the hypo
indicator comes next. The following is displayed (see Chapter 3.10):
Press the M button to turn the alarm clock function on. H is displayed.
If you press the M button again, function is turned off.
reappears and the alarm clock
60
Settings
Settings
61
3
required hour is displayed.
Setting alarm times
The procedure for setting the alarm time is the same for each alarm.
Alarm 1 is used below for illustrative purposes. The number and subsequently and in the display stand for Alarms 1, 2 and 3.
The factory setting is 0:00 (24-hour format) or 12:00 a.m. (12-hour format). This time means that alarm 1 is turned off. Only when you set a
different alarm time is Alarm 1 turned on.
First the hour is set, and then the minutes.
The minute setting comes next.
The minutes flash at top left of the display.
24-hour
format
The hour flashes at top left of the display.
24-hour
format
12-hour
format
required minutes are displayed.
12-hour
format
62
Settings
Settings
63
3
3
Notes
The setting for Alarm 2 comes next, and then for Alarm 3.
i
Alarm 2
You do not have to set all three alarm times; you can set just one
or two times. When you have set your alarm times and the hour
for the next alarm flashes:
" press the S button repeatedly until you reach the hypo indicator setting (see Chapter 3.10),
24-hour format
or
12-hour format
" If you do not wish to set a hypo indicator, press the Test button to turn the meter off.
i
Alarm 3
24-hour format
12-hour format
You can turn off individual alarms by setting their time to 0:00
(24-hour format) or 12:00 a.m. (12-hour format). Any other time
means that the alarm clock function is turned on for this time.
To set the alarm clock function for midnight you must therefore
set the time to one minute to midnight (23:59 or 11:59 p.m.) or to
one minute after midnight (0:01 or 12:01 a.m.).
To set the alarm times for Alarm 2 and Alarm 3, proceed as described
for Alarm 1.
The hypo indicator setting comes next.
64
Settings
Settings
65
i
i
The meter can only remind you to perform a blood glucose test
when the year, time and date have been set in the meter. If you
lose the year, time and date settings while replacing the batteries
(see Chapter 9), you must re-enter these in order for the alarms
to be active. The settings for the alarms themselves will not have
been lost.
If you have turned the alarm clock function on, the meter will
always beep to remind you to test your blood glucose even if the
beep tone itself is turned off. The beep tone setting has no influence on the alarm clock function.
i
If you turn the alarm clock function off entirely (
times you have set remain saved nevertheless.
i
If the meter is already on when an alarm is due, whether for a
blood glucose test or some other reason, the alarm is suppressed. The alarm sounds as soon as you turn the meter off or it
turns off automatically. The alarm does not sound until then.
66
Beep tone or
Acoustic Mode
Brightness
of the display
On / Off / Acoustic
Mode
Low / Medium / High
Time
Date
Alarm clock
function
Hypo indicator
Hours, Minutes
Month, Day
Off / 1, 2 and 3
(hour, min)
Off / Level
), the alarm
Settings
3
3.10 Setting the hypo indicator
Year
Time-and-date
format
24-hour / 12-hour
You are here
To help you to recognize a possible hypo, you can set the meter to let
you know when your test result indicates a low blood glucose. You can
select what blood glucose level you want this indicator to have.
As soon as a test result is below the level you have set, you see the
flashing
symbol displayed along with the result. If the beep tone
( H) is turned on, you hear 5 short double beeps (after the beep you
hear when the result is displayed). The 5 short double beeps are not
heard when the beep tone is set to off or Acoustic Mode ( H) is set to
on.
Settings
67
3
You can choose between the following hypo indicator levels:
" 3.3 mmol/L (60 mg/dL)
When your chosen level is displayed, press the Test button to turn
the meter off. The hypo indicator is then set to this level.
" 3.9 mmol/L (70 mg/dL)
" 4.4 mmol/L (80 mg/dL)
The hypo indicator (
the display.
Notes
symbol) is factory set to off. flashes in
The hypo indicator is only reliable if your hypo indicator level has
been properly selected. Therefore we strongly recommend that
you talk to your healthcare professional about what blood glucose
level is your hypo level before you set the indicator. This function
is no substitute for hypoglycaemia training by your doctor or diabetes team.
i
68
Settings
Settings
The hypo indicator level may vary from person to person. Therefore we recommend leaving the hypo indicator function turned
off when using the meter in a professional setting. See chapter
10 for more information.
69
4
Testing blood glucose
4.1
Preparing to test blood glucose
You can choose one of 11 different penetration depth settings to suit
your own skin type. You can use the finger pricker either docked with
the meter, or undocked.
You will need the following items to carry out the test:
" the meter with a test strip drum inserted
" the finger pricker to obtain blood
The finger pricker has a plunger at the top (see illustration in Chapter
1.2). This plunger has three functions:
" a lancet for the finger pricker
" priming the finger pricker
Wash your hands with warm water and soap, and dry well. This
stimulates blood flow and ensures that the puncture site is clean.
" triggering the lancet to obtain blood
4.2
You can perform all of these functions using just one hand, as to activate a function you only have to press the plunger down.
Preparing the finger pricker
You use the finger pricker to obtain blood from a fingertip or earlobe, or
from other (alternative) sites. If you wish to obtain blood from alternative
sites (such as the base of the thumb, forearm, upper arm, calf or thigh),
you must replace the normal black cap on the finger pricker with a special, transparent AST cap (which is included in the pack or can be
obtained by calling the Accu-Chek Customer Careline free on
0800 701000 (UK) or 1800 709600 (Ireland)). Please read the instructions for use that come with the AST cap before you use blood from
alternative sites to test blood glucose.
70
" ejecting the used lancet
To obtain blood you first need to insert a lancet and then set the penetration depth.
71
4
Notes
4.2.1 Undocking the finger pricker from the meter
patient self-monitoring by a single person. The finger pricker
must not be used on more than one patient due to the risk of
infection.
If you wish to use the finger pricker undocked from the meter, detach it
as follows:
Healthcare professionals testing blood glucose in a multi-patient
setting must not use the Accu-Chek Softclix Plus finger pricker to
collect blood and should therefore remove the finger pricker from
the meter. The finger pricker may be replaced with a blanking
plate (see Chapter 10.1).
/
0
Only use Accu-Chek Softclix lancets in your Accu-Chek Softclix
Plus finger pricker. Using any other lancets may damage the finger pricker or impair its function. This may result in injury.
Push the slide button in the direction indicated by the arrow (1) and
hold it there.
Withdraw the finger pricker in the direction indicated by the arrow
(2).
72
73
4
4.2.2 Docking the finger pricker onto the meter
4.2.3 Inserting the lancet
4
Hold the meter so it is horizontal, with the recess for docking the finger pricker pointing upwards.
Remove the cap from the finger pricker.
Place the flat face of the finger pricker on the lower end of the
recess, with the plunger facing towards the slide button.
Slide the finger pricker forward along the meter in the direction indicated by the arrow, until it locks with an audible CLICK. The guides
along the inside of the recess must engage with the grooves along
the finger pricker.
Slide a new lancet into the lancet holder, and push it in until you
hear it CLICK into place.
74
75
Notes
Dropping the finger pricker with a lancet inserted may loosen the
lancet in its holder. In that case the lancet is no longer properly
lodged and cannot be used to obtain blood.
In rare cases the lancet may even protrude from the cap. In a
case such as this you might injure yourself on the lancet. Therefore take great care not to touch the front of the cap.
Should you drop the finger pricker, please pick it up with care.
Remove the cap from the finger pricker. Take care to avoid the
lancet so as not to injure yourself. Always eject and dispose of
the lancet if the finger pricker has been dropped (see Chapter
4.5). Afterwards, re-attach the cap without inserting a lancet.
Press the plunger all the way down twice. Only then insert a lancet again.
Remove the protective cap from the lancet with a twisting motion.
/
0
i
For blood collection, the cap must be on the finger pricker. Without this cap, the finger pricker cannot be primed, nor can the lancet be triggered. Instead, the lancet is ejected when you press
the plunger.
Press the cap back on the finger pricker.
The locating notch in the cap (1) must be directly aligned with the
locating line on the finger pricker (2). The cap snaps into place with
an audible CLICK.
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77
4
4.3
Notes
4.3.1 Turning the meter on
i
While the display test is running, you may press the Test button to
turn the meter off again. If you do, a test strip is not advanced.
i
If additional lines appear during the display test or parts of symbols are missing, please contact the Accu-Chek Customer Careline free on 0800 701000 (UK) or 1800 709600 (Ireland). If the
numeric field (mmol/L meter) or (mg/dL meter) is
affected, the meter may not show your test results correctly.
Press the Test button to turn the meter on.
Following the display check (see Chapter 2.2.2) a test strip is automatically advanced and the test strip symbol and drop symbol flash in the
display.
You now have about 5 minutes in which to draw up blood with the test
strip.
78
79
4
4.3.2 Obtaining blood
4
All the fingertips and both the earlobes are suitable for obtaining blood.
We recommend obtaining capillary blood from the side of the fingertip,
as this causes the least amount of pain.
You can choose the penetration depth from a possible 11 settings ranging from 0.5 to 5.5. Your chosen penetration depth is visible in the window, e.g.:
Rotate the Comfort Dial (cap) until you reach your chosen setting.
The cap snaps into place at each penetration depth setting.
We recommend a low setting (e.g. 2) if you are using the finger pricker
for the first time.
To obtain blood you first need to prime the finger pricker.
The larger the number, the greater the penetration depth.
The half-settings – e.g. 2.5 – are identified by a dot. The setting 2.5 is
set when the dot is between 2 and 3 in the window. For technical reasons the setting 5.5 is not identified by a dot. Setting 5.5 is set when
you rotate the cap beyond setting 5 and the cap snaps into place.
Press the plunger all the way down.
The plunger returns about a third of the way. The finger pricker is now
primed.
80
81
Notes
Use a new lancet each time you obtain blood. This not only
reduces the risk of infection but also helps ensure virtually painfree blood sampling.
Do not prime the finger pricker until you are ready to collect
blood. Keeping the finger pricker in this primed state can cause
parts to become misshapen through tension, impairing its operation.
i
Firmly press the finger pricker against the chosen puncture site.
The amount of blood that emerges at the puncture site depends
on the penetration setting and the pressure used to hold the finger pricker against the skin. If the amount of blood you obtain is
too small, try again, applying more pressure this time. If you still
obtain insufficient blood, repeat the procedure with progressively
deeper settings. If too much blood emerges, reduce the penetration depth.
You will feel the slightly raised ring against your skin. This is the pinhole through which the tip of the lancet emerges.
Press the plunger all the way down.
This triggers the lancet, which penetrates the skin.
Using gentle pressure, massage the finger towards the fingertip to
encourage a drop of blood to form.
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83
4
4.3.3 Drawing up blood with the test strip
4
Wait until the test strip symbol and drop symbol flash in the display
and the meter beeps (only when the beep tone is turned on).
Hold the meter so the test strip is pointing downwards (see illustration).
Immediately after the drop of blood has formed: Hold the tip of the
test strip against the drop of blood so the black notch is touching
the drop of blood.
The test strip draws up blood.
Move the finger away from the test strip as soon as the hourglass
symbol is displayed and the meter beeps (only when the beep
tone is turned on).
84
85
The test strip has then drawn up enough blood, and test starts. The
hourglass symbol indicates that the meter is busy performing a test.
Notes
Do not touch the test strip unless you are drawing up blood with
it. Residues (e.g. of food, drinks or skin cream) on the skin can
find their way onto the strip and may produce incorrect results.
Incorrect results can cause the wrong therapeutic decision to be
taken and so produce adverse health effects.
Testing is complete after approx. 5 seconds. The result is displayed and
the meter beeps (only when the beep tone is turned on). At the same
time the meter automatically saves the result to memory.
Wipe the puncture site with a clean, dry tissue.
We recommend covering the puncture site to keep dirt out.
86
Take care not to bend the test strip either before or while you
draw up blood. Do not bend or move the test strip while the test
is in progress. Bending or moving the test strip can produce an
incorrect result or cause error message E-5 (see Chapter 12.2) to
be displayed.
Allowing the test strip to draw up blood too early, i.e. before the
test strip symbol and drop symbol flash, can produce an incorrect
result or cause error message E-5 (see Chapter 12.2) to be displayed.
Turn the meter off with the Test button so as to eject the test strip
(see Chapter 4.4), and dispose of the test strip. Repeat the blood
glucose test with a new test strip.
87
4
Always hold the meter so the test strip is pointing downwards
when you are drawing up blood with the test strip. If you hold it
so the test strip is pointing upwards or sideways or you put the
meter down on a surface with the test strip still in it, blood can
enter the meter and contaminate it.
i
88
i
If the test does not start despite the fact that you have held the
drop of blood against the test strip, the test strip drew up too little
blood. In this case you can, within a certain period, draw up more
blood with the test strip (see the package insert that came with
the test strip drums).
i
If the meter beeps not once but several times when displaying
the result, either the hypo indicator is turned on and the result is
below the limit (see Chapter 3.10) or Acoustic Mode is turned on
(see Chapters 3.3 and 6).
As soon as the test strip symbol and drop symbol flash in the display, you have approx. 5 minutes to draw up blood with the test
strip. If you have not drawn up blood within this time, i.e. testing
has not started, the meter turns off automatically. In this case,
press the Test button so as to eject the test strip (see Chapter
4.4), and dispose of the test strip. Start the blood glucose test
again with a new test strip.
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4
4.4
Notes
Ejecting the test strip
Hold the meter over a waste bin with the test strip pointing downwards.
Always turn the meter off by pressing the Test button, so as to
eject the test strip. Do not pull the test strip out. If you do pull the
used test strip out, blood can enter the meter and contaminate it.
Do not push an ejected test strip back into the test strip drum.
This includes any unused test strips that you have ejected by
accident. These test strips can produce incorrect results. Incorrect results can cause the wrong therapeutic decision to be taken
and so produce serious adverse health effects.
i
If you do not turn the meter off, it turns off automatically after
approximately 60 seconds. The test strip then remains in the
meter.
The next time you turn the meter on, it ejects this test strip and
automatically turns off again.
i
You can dispose of used test strips with your regular household
waste.
The used test strip drops out.
Before the meter turns off, it shows you the number of test strips
remaining in the drum (see Chapter 2.3.2).
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91
4
4.5
Ejecting the used lancet
If the lancet does not drop out:
4
Keep the plunger pressed down.
Remove the cap from the finger pricker.
Hold the finger pricker upright above a waste bin.
Hook the edge of the white “collar” of the cap behind the platform of
the lancet.
A cut-out area on the inside of the lancet holder makes it easy to hook
the lancet platform (see illustration).
Use the white collar to pull the lancet out.
Press in the plunger until it CLICKS.
The lancet drops out.
Press the cap back on the finger pricker.
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93
Notes
4.6
Make sure the lancet has dropped out. Inadvertently leaving the
lancet in the finger pricker may result in personal injury.
Carefully dispose of used lancets so that the needles cannot
cause injury.
i
You must remove the cap to eject the lancet. If you leave the cap
in place, pressing the plunger will prime the finger pricker.
Symbols you see before, during or after testing and what
they mean
4
You may see the following symbols displayed before, during or after a
test. For further information please see Chapter 12.1.
The beep tone (H) or Acoustic Mode (H) is set to on.
You have turned on at least one alarm.
While the result is displayed:
You have turned the hypo indicator on. The result is below the
indicator level you set. If the beep tone (H) is turned on,
you hear 5 short double beeps (after to the beep you hear
when the result is displayed).
The batteries are running low.
The use-by period for the test strip drum has expired.
You inserted a partly used test strip drum.
The temperature is outside the permitted range of +10 °C to
+40 °C.
The meter is prompting you to perform a performance check.
The test strip has drawn up control solution and the meter
has flagged the result as a performance check.
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95
Instead of a result:
The result is above 33.3 mmol/L (600 mg/dL).
If you press the S button again, the asterisk disappears again.
The result is saved together with the asterisk as long as the asterisk is
displayed and you press the Test button to turn the meter off.
Instead of a result:
The result is below 0.6 mmol/L (10 mg/dL).
4.8
4.7
Evaluating results
Flagging special results
You can flag special results, e.g. results obtained from alternative site
testing or after exercise, with an asterisk .
You can only do this while the result is displayed and as long as you
have not yet turned the meter off.
No other symbol
Asterisk
If the displayed test result agrees with the way you feel, follow
your doctor’s advice. If the displayed test result does not agree
with the way you feel, please perform a performance check with
an Accu-Chek Compact Autocontrol control solution and a new
test strip (see Chapter 7). Then perform another blood glucose
test. If the new test result still does not agree with the way you
feel, please contact your doctor.
Do not change your treatment based on just one result.
While the result is displayed:
Press the S button. The asterisk appears in the display.
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97
4
4.8.1 Measuring range
4.8.2 Implausible results – possible causes of error
Your meter measures blood glucose within a defined range
(0.6−33.3 mmol/L or 10−600 mg/dL).
If your meter repeatedly displays implausible results or error messages,
please check the following points:
Values below this range are displayed as:
The result is less than 0.6 mmol/L (10 mg/dL).
Values above this range are displayed as:
Did you perform the blood glucose test according to the reference manual (see Chapter 4.3)?
yes
Did you wash your hands with warm water and soap to
improve blood flow and to remove any residues (e.g. of food,
drinks, or skin cream)? Did you dry your hands well?
yes
Did you massage your finger only gently in the direction of the
fingertip?
yes
Did you bend the test strip either before or while you were
drawing up blood with it?
no
Did you wait for the test strip symbol and drop symbol to flash
in the display before drawing up blood with the test strip?
yes
Did you draw up blood with the test strip immediately after
the drop of blood formed?
yes
Did you bend or move the test strip while the test was in
progress?
no
The result is greater than 33.3 mmol/L (600 mg/dL).
These results are not used to calculate averages (see Chapter 5.3).
98
99
4
Did you perform the test within the correct temperature range
(+10 °C to +40 °C)?
yes
Has the test strips’ use-by date expired (see label on the container of the test strip drum next to the symbol)?
no
Has the 90-day use by period for the test strip drum expired
(see Chapter 2.3.1 and possibly the clock symbol
in the
meter’s display)?
no
Are the test strip guide and measuring window clean?
yes
Have you observed the proper storage conditions for the
meter and test strip drums (see Chapter 11 and the package
insert that came with the test strip drums)?
yes
Have you paid attention to the sources of error stated in the
package insert that came with the test strip drums?
yes
If you give the responses as specified to all these questions and
still receive implausible results or error messages, please call the
Accu-Chek Customer Careline free on 0800 701000 (UK) or
1800 709600 (Ireland).
5
Using the meter as an electronic notebook
5.1
Memory
Your meter has a 500-value memory for saving results together with the
time and date (only when you have set the time and date). You do not
need to save the results manually. The meter automatically saves and
numbers the results. The most recent result always occupies memory
location 1, the preceding one location 2, etc. up to location 500. When
all of the locations are occupied and a new test is performed, the result
in location 500 is erased, the other results are shifted one place back in
time, and the most recent result is saved in memory location 1.
In addition to the result, the time and the date, your meter also saves all
other information that is relevant to that test. For example, results
flagged as performance checks (see Chapter 7) are displayed together
with the bottle symbol . Results obtained at a temperature outside the
permitted range are displayed with the thermometer symbol . Please
refer to Chapter 12.1 for a complete list of symbols which may be displayed.
If your meter has been dropped, that can also lead to implausible results
or error messages. If it has, again please call the Accu-Chek Customer
100
101
5
5.2
Retrieving results from memory
Retrieving older results from memory:
5
Press the M button once to move towards the next older result
saved.
With the meter turned off, press the M button.
Following the display check (see Chapter 2.2.2), the most recently saved
result is displayed together with the time, date and
.
Time and date at the time
of performing a test
102
With the M button you can move back until you reach the oldest result
(max. 500 results). If you press and hold down the M button, the results
are fast-scrolled, starting slowly and then speeding up.
To move back again towards the most recently saved results:
Press the S button. To fast-scroll, press and hold down the S button.
103
By pressing the S button you can scroll back to the most recent result.
Memory location 1
Most recent result saved
You can exit memory at any time:
To do this, press the Test button.
5
The meter turns off.
Memory location 2
Memory location 3
Notes
i
Always turn the meter on with the M button if you intend to
review results held in memory.
If you turn the meter on with the Test button and there is a drum
in the meter, a test strip will be advanced.
i
If no result has been saved in the meter, just three horizontal bars
are displayed.
Memory location 499
Memory location 500
Oldest result
If the beep tone (H) or Acoustic Mode (H) is turned on, a beep
sounds each time
" when you reach the oldest result (i.e. the memory location with
the highest memory location number, see Chapter 5.1), and you
press the M button,
" when you reach the most recently saved result again and you press
the S button.
104
105
i
If the time and date were not set at the time of testing, then the
memory location number is displayed instead of the time and
date.
Memory location number
5.3
Average, highest value and lowest value for 7, 14 and 30
days
The meter can display the average values of results from the last 7, 14
or 30 days. Also, you can request that the lowest and highest values be
displayed for these 3 periods. All results falling within the relevant
period are included in the calculation. The current day is always
included in the calculation. If more than 500 test results were saved
during this period, the calculation will be based on the last 500 test
results.
With the meter turned off, press the M button.
If the memory contains both results that were saved together
with the time and date and results that were not saved with this
information, then you will see results shown together with their
time and date as well as results shown only with their memory
location number.
i
i
The meter turns off automatically if you have not pressed a button for 60 seconds.
106
Following the display check (see Chapter 2.2.2), the most recently saved
result is displayed together with the time, date and
.
is short
for memory.
107
5
Press the M and S buttons at the same time.
For each of these three periods you can ask the meter to display the
lowest and the highest values.
The average of the results from the last 7 days is displayed.
5
/
Lowest value
0
Average
Highest value
/ The number of results n used in the calculation is displayed at top
left (in this example: 30).
0 The number of days for which the average was calculated is displayed at top right (in this example: 7).
Again press the M and S buttons together to move to the other averages.
The 7-day average is followed by the 14-day and 30-day averages, and
then again by the 7-day average.
108
When one of the three averages is displayed:
Press and hold down the M button to view the lowest value.
Press and hold down the S button to view the highest value.
As long as you hold the M button or S button down, the lowest blood
glucose value (and the highest blood glucose value, respectively) which
you obtained within the period in question is displayed along with its
time and date. If, for instance, the 7-day average was shown, then the
lowest or highest value relates to the last 7 days.
109
When you release the button, the display reverts to the average.
You can exit from the average value display at any time:
To do this, press the Test button.
Memory location 1
Most recent result saved
+
Notes
7-day period
Lowest value
Average
Highest value
+
i
Results flagged as performance checks with the bottle symbol
are not included in the calculations.
i
Results shown as being
or are not included in the average
calculations, but are displayed as the lowest and highest values,
respectively.
i
The meter calculates the average value, the lowest value and the
highest value for a period even when the saved results cover a
shorter period. Example: tests were only performed in the last 5
days. In addition, either no other results were saved or the results
that were saved are more than 30 days old. Consequently the
results for the last 5 days are used for calculating the average,
the lowest value and the highest value for all three periods (7, 14
and 30 days).
14-day period
Lowest value
Average
Highest value
+
30-day period
Lowest value
5
The meter turns off.
Average
Highest value
+
7-day period
110
111
i
If a large number of results were saved within one period, calculation of the average may take a while.
flashes in the display
while the calculation is in progress.
i
If no results were saved in memory for the period in question,
three horizontal bars
are displayed instead of a numerical value. If, for example, the results are more than 7 days old,
the average, lowest value and highest value cannot be calculated
for 7 days.
i
The meter can only perform the necessary calculations as long
as the results were stored together with the time and date. If you
have not entered the time and date, three horizontal bars
are displayed instead of the numerical values.
i
In the event that you changed the date or time, then performed a
test and afterwards re-set the date/time, the meter only includes
results it saved in uninterrupted chronological order. If the chronological order was interrupted, the earlier results are ignored. If
you have not performed any tests since you made the change,
three horizontal bars
are displayed instead of a numerical value.
112
i
If the memory contains both results that were saved together
with the time and date and results that were saved without this
information, the averages and respective lowest and highest values will only be calculated from results saved with the time and
date that come chronologically before the first result without the
time and date. Example: The meter saved 150 results over a
period of 50 days. The result in memory location 51 was saved
without the time and date. The results in memory locations 1 to
50, which were saved together with the time and date, cover a
20-day period. For calculation of the 7- and 14-day averages,
those results are included that are within the period in question.
The 30-day average is calculated from all 50 results, even if
these only covered a 20-day period. The results after the result
without the time and date (memory location 52 and higher) are
no longer available for calculation of averages, even if they were
saved with the time and date.
i
i
The meter turns off automatically if you have not pressed a button for 60 seconds.
113
5
5.4
Downloading test results to a PC, handheld computer or a
special evaluation system
The infrared window is located at the front end of the meter.
The meter has an inbuilt infrared window permitting wireless data
downloading to a suitably equipped PC, handheld computer (PDA), or
special evaluation systems.
5
Roche Diagnostics offers a variety of special hardware and software
that extend the integrated notebook functions of your meter. These
products enable you and your doctor to manage your data more effectively and, through their graph and table views, make it easier for you to
understand your results.
Depending on the type of analysis you intend to perform, you will require
a special software product and/or special hardware products. For further
information please contact the Accu-Chek Customer Careline free on
0800 701000 (UK) or 1800 709600 (Ireland).
114
Be sure to read the operating instructions supplied with the software
and hardware you are using. These will include instructions on how
to download your data.
Make the receiving end (software product or hardware) ready to
download the results.
115
Position the meter 5-20 cm away from the infrared window of the
receiving end. Point the two infrared windows towards one another.
If necessary, start the results download at the receiving end (software product or hardware).
During the download both arrows flashed alternately. During the download only those results that are new to the receiving end, i.e. those have
not yet been downloaded, are sent.
With the meter turned off, press the M and S buttons at the same
time.
The meter turns on. Following the display check (see chapter 2.2.2), the
following appears:
116
Once downloading has finished, the arrows stop flashing and the meter
is automatically turned off by the receiving end.
If the meter is not turned off, press the Test button to turn it off.
117
5
" Another device with an infrared source turned on or a strong
light source is too close to the two infrared windows.
Remove the device or light source and start the download
again.
Notes
i
Your results can only be fully analysed if all of the results have
been saved together with the date and time, i.e. as long as you
have set the date and time.
i
i
The results remain in the meter’s memory following downloading.
i
If the results download does not occur (the arrows do not start
to flash) or was incomplete, the meter turns itself off automatically after approximately 5 minutes.
This is what might have happened:
" An object, for instance, is blocking communication between
the two infrared windows.
Remove the object and start the download again.
You cannot perform a test while results are being downloaded.
" An error occurred at the receiving end.
Read the relevant manual(s).
i
If you already have a hardware or software product from Roche
Diagnostics to enable you to transfer and evaluate results, it may
not recognize more recent meters, so the results will not be
downloaded. You may need a more recent software version for
your hardware or software product. In this case please contact
the Accu-Chek Customer Careline free on 0800 701000 (UK) or
1800 709600 (Ireland).
i
Data transfer does not follow the IrDA standard (IrDA stands for
Infrared Data Association).
" A download error occurred.
Start the results download again.
" The infrared windows are too far apart or not properly facing
one another.
Reduce the distance between the two infrared windows to
5-20 cm and position them so they are pointing towards one
another. Start the results download again.
118
119
5
6
Acoustic Mode
Acoustic Mode is intended for persons who are visually impaired. When
Acoustic Mode is turned on, the meter guides you through the blood
glucose test using beep tones; it also outputs the result as a series of
beeps. The meter beeps additionally when the batteries are almost
exhausted, the test strip drum is empty, or an error message is displayed.
Chapter 3.3 describes how to turn Acoustic Mode on.
Visually impaired persons need a sighted person to instruct them
in the use of the meter and to assist them with all aspects of its
operation. Visually impaired persons must not test their blood
glucose without assistance from a sighted person.
An intimate knowledge of how results are represented as beeps and
how to distinguish results from other beeps is crucial to reliably recognizing the result.
The chapters that now follow explain the beep tones in detail. In addition, training software (the BeepLearn-Programm) to help you interpret
results announced in the form of beeps is available on CD from the
Accu-Chek Customer Careline free on 0800 701000 (UK) or 1800
709600 (Ireland). Practise listening to beeps from actual tests or from
the training software together with a sighted person until you can clearly
recognize and interpret the results and other beeps you will hear.
There are two types of beep tone, differing in pitch. Warnings have a
higher tone (Tone 2, represented below as — ) than the other beep
tones (Tone 1, represented below as — ). The following table shows
which tone sounds for which event.
Turning on
Chapter 6.1
Meter ready to test
Chapter 6.2
Start of test
Chapter 6.2
Announcement of the result
Chapters 6.3 and
6.4
Signal that results are due to be
announced
Chapters 6.3 and
6.4
Announcement of an error message
Chapters 6.2 and
6.5
Notification that the batteries are
almost exhausted
Chapter 6.5
Notification that the drum is
empty
Chapter 6.5
6
Tone 1
Tone 2
(warning)
If you have problems determining the results from the beeps, you should
not use Acoustic Mode.
120
Acoustic Mode
Acoustic Mode
121
6.1
Beep tones at power-on
6.2
Beep tones during testing
When Acoustic Mode is set to on, you hear a long beep ( — ) when you
turn on the meter.
Following the power-on beep and the 1 – 2 – 3 sequence of beeps, you
will hear the following while you test:
This is irrespective of which button you use to turn the meter on:
" a single beep when the meter is ready to test so you can let the test
strip draw up blood or control solution,
" the Test button in order to perform a test (see Chapter 4.3.1)
" a single beep when the test strip has drawn up sufficient blood or
control solution and the test is starting,
" the S button in order to change settings (see Chapter 3)
" the M button in order to retrieve results from memory (see Chapter 5)
" several beeps each time the meter displays an error message (see
Chapter 6.5).
" the M and S button in order to send results (see Chapter 5.4)
If you press the Test button or M button to turn the meter on, you first
hear the long power-on beep followed by 6 further beeps spaced as
1 – 2 – 3 ( – – – – – – ).
6.3
Announcement of the result following a test
In Acoustic Mode, whenever your meter displays a result following a
blood glucose test, it also announces the result as a series of beeps. The
result is not treated as an entity, but is broken down into individual digits.
Examples:
" The result 7.6 mmol/L is announced as 0 – 7 – decimal point – 6.
" The result 138 mg/dL is announced as 1 – 3 – 8.
122
Acoustic Mode
Acoustic Mode
123
6
Each digit is represented by the corresponding number of beeps; e.g. 4
beeps for the number 4 ( – – – – ). Zero is represented by a long beep
( — ).
The result is announced three times in succession. Each result is preceded by two short beeps ( - - ) . Altogether, therefore, you hear: - result - - result - - result.
mg/dL meters
First the hundreds are announced, then the tens, and finally the units.
There is a short pause between each group of beeps. The hundreds are
always announced, even when the result is below 100. The hundreds in
this case are represented by 1 long beep, signifying zero.
Examples:
mmol/L meters
First the tens are announced, then the units, then the decimal point and
finally the tenths. There is a short pause between each group of beeps.
The tens are always announced, even when the result is below 10. The
tens in this case are represented by 1 long beep, signifying zero. The
decimal point is represented by 1 very short beep ( . ).
Examples:
" The result 13.8 mmol/L is announced as follows:
1 beep – pause – 3 beeps – pause – 1 very short beep – pause– 8
beeps
( – – – – . – – – – – – – – )
" The result 4.0 mmol/L is announced as follows:
1 long beep (for 0 tens) – pause – 4 beeps – pause – 1 very short
beep – pause – 1 long beep
( — – – – – . — )
124
Acoustic Mode
" The result 180 mg/dL is announced as follows:
1 beep – pause – 8 beeps – pause – 1 long beep
( – – – – – – – – –
— )
" The result 72 mg/dL is announced as follows:
1 long beep (for 0 hundreds) – pause – 7 beeps – pause – 2 beeps
( — – – – – – – –
– – )
Results that are lower than 0.6 mmol/L or 10 mg/dL and are displayed
as
are announced acoustically as 0 – 0 – 0 and 0 – decimal point –
0, respectively.
Results that are higher than 33.3 mmol/L or 600 mg/dL and are displayed a are announced acoustically as 9 – 9 – 9 and 9 – 9 – decimal point – 9, respectively.
Acoustic Mode
125
6
Notes
Note
i
If the 7-day average cannot be calculated, three horizontal bars
are displayed. This is signalled acoustically with 3 long
beeps representing 3 zeroes ( — — — ).
i
If you press the M button to turn the meter on, you first hear the long
power-on beep followed by the beep sequence 1 – 2 – 3 and then the
most recent result.
If the result that was most recently saved is flagged by the bottle
symbol as being a performance check result (see Chapter 7), it
is announced in the same way as any blood glucose test result.
There is no acoustic signal to identify it as a performance check
result. Likewise, there is no acoustic signal to identify a result
flagged by an asterisk as being a special result (see Chapter 4.7).
i
Only the average for the last 7 days is announced acoustically. The lowest and highest results within this period are not announced acoustically.
The 14 and 30-day averages and the lowest and highest results
within these two periods (see Chapter 5.3) are not announced
acoustically in Acoustic Mode, but only displayed.
i
If no result has been saved, just three horizontal bars
displayed. There is no acoustic announcement.
i
6.4
Information or warnings in the form of symbols (e.g. drum symbol
or
symbol, see Chapter 12.1) that are displayed together
with the result are not announced acoustically.
Announcement of results and average values from memory
Only the last (most recent) result that was saved can be announced
acoustically.
are
The announcement follows the same pattern as any result that is
announced directly following a test.
126
Acoustic Mode
Acoustic Mode
127
6
7
6.5
Announcement of warnings and error messages
Checking your meter
To ensure your results are always dependable, you should periodically
check the performance of your meter.
When the batteries will soon be exhausted or the last test strip in a
drum has been used, The meter issues an acoustic warning. This consists of two short beeps sounded three times in succession
( - - - - - - ).
Do this by performing a performance check using the Accu-Chek Compact Autocontrol control solutions, each time
The warning is given at different times.
" after you have replaced the batteries.
" Batteries are almost exhausted (the battery symbol is displayed,
see Chapter 9):
This acoustic warning is sounded when you turn the meter on.
" after your meter has displayed the bottle symbol
perform a performance check,
" You have used the last test strip in the drum (H> and drum symbol
flash, see Chapters 2.3 and 12.2):
The acoustic warning is given after you have pressed the Test button
to turn the meter off.
If error messages ( with a number or the , see Chapter 12.2) are
displayed, these are announced by two short beeps sounded four times
in succession ( - - - - - - - - ). This sequence is sounded only
once and is not repeated. The same sequence of beeps is sounded for
all error messages, i.e. they are not differentiated acoustically.
128
Acoustic Mode
" after you have opened a new pack of test strip drums,
7
prompting you to
" after you have cleaned the measuring window of the meter,
" if your result does not agree with how you feel.
You can obtain control solution free from Roche Diagnostics by calling
the Accu-Chek Customer Careline free on 0800 701000 (UK) or 1800
709600 (Ireland).
Checking your meter
129
7.1
7.2
What you need
To perform a performance check you need the following items:
Performing a performance check
Read the package insert that came with the control solutions.
" meter with a test strip drum inserted
" Accu-Chek Compact control solution Autocontrol G1 (low glucose
concentration) or Autocontrol G2 (high glucose concentration)
" Concentration table for the control solutions (see label on the container the test strip drum came in).
7
Press the Test button to turn the meter on.
Note
i
130
The concentration table for the control solutions can be found on
the peel-off label attached to the drum container. When conducting the performance check, always make sure that the peel-off
label with the concentration table belongs to the test strip drum
that is currently in the meter.
Checking your meter
Following the display check (see Chapter 2.2.2) a test strip is automatically advanced, and the test strip symbol and the drop symbol flash in
the display.
Checking your meter
131
You now have about 5 minutes in which to draw up control solution with
the test strip.
Take a bottle of control solution.
Open it and wipe the tip of the dropper with a clean, dry paper towel
in order to remove any dried-on residues.
Invert the vial and hold it downwards at an angle. Squeeze it gently
until a small drop is suspended from the tip.
7
Hold the meter so the test strip is pointing downwards (see illustration).
Apply the drop to the surface of a clean, easily washable object
made of glass, porcelain or stainless steel (e.g. a plate or spoon).
Hold the tip of the test strip to the drop of control solution.
132
Checking your meter
Checking your meter
133
The test strip draws up the control solution through the black notch.
Immediately after the result is displayed:
Move the test strip away from the control solution as soon as the
hourglass symbol is displayed and the meter beeps (provided the
beep tone is turned on).
Compare the result with the concentration table printed on the peeloff label attached to the drum container.
The result must be within the concentration range stated.
The test strip has then drawn up enough control solution, and testing
starts. The hourglass symbol indicates that the meter is busy performing a test. The meter automatically detects that the test strip has
drawn up control solution. The bottle symbol appears additionally in
the display when the test starts.
The concentration table has two rows and two columns. Rows 1 and 2
contain concentration data for the two different control solutions, G1
and G2; the columns are for the two different units of measurement,
mmol/L and mg/dL.
Make sure you compare the result with the concentration data stated for
the control solution you used and the unit of measurement your meter
displays.
Accu-Chek® Compact Autocontrol
Testing is complete after approx. 5 seconds. The result is displayed and
the meter beeps (provided the beep tone is turned on). The meter at the
same time saves the result together with the bottle symbol . The saved
result is thus recognizable as being a performance check result.
mmol/L
mg/dL
G1
1.7-3.4
31-61
G2
7.1-9.6
127-172
Unit of
measurement
The figures shown are for
illustration only
Control
solution used
134
Checking your meter
Checking your meter
135
7
Subsequently hold the meter directly above a waste bin with the test
strip pointing downwards.
i
You can dispose of empty or only partly used bottles of control
solution together with your regular household waste.
Please refer also to the notes in Chapters 4.3 and 4.4.
The used test strip drops out.
Before the meter turns off, it shows you the number of test strips
remaining in the drum (see Chapter 2.3.2).
Wipe the tip of the dropper with a clean, dry paper towel and close
the bottle tightly.
Notes
i
The control solution you apply to a washable object must come
from a suspended drop. Do not use the drop if it has run down
the outside of the tip of the dropper. This may lead to results that
are too high.
i
Control solution that is to be drawn up by the test strip must just
have been freshly applied to the object. The control solution must
not be left exposed on the surface for any length of time, or it
may give results that are too high.
i
Results flagged as performance checks with the bottle symbol
are not included in the calculation of averages and lowest and
highest results.
136
Checking your meter
7.3
Possible causes of error during the performance of performance checks
If the result is outside the stated concentration range, perform a second
performance check. If the result of this second check is outside the concentration range as well, please check the following points:
Did you perform the performance check as described above?
yes
Did you wipe the tip of the dropper before you applied control
solution to the surface of the washable object?
yes
Did you use a suspended drop of control solution?
yes
Was there prolonged contact between the control solution and
the washable object?
no
Did you bend the test strip either before or while you were
drawing up control solution?
no
Did you wait for the test strip symbol and drop symbol to flash yes
in the display before drawing up control solution with the test
strip?
Checking your meter
137
7
Did you bend or move the test strip while the test was in
progress?
no
Did you compare the result with the concentration data specifically relating to the control solution you used?
yes
Does the concentration table belong to the test strips that are
currently in the meter?
yes
Did you perform the test within the correct temperature range
(+10 °C to +40 °C)?
yes
Has the use-by-date for the control solution or the test strips
expired (see label on the bottle and the test strip drum next to
the symbol)?
no
Has the 90-day use-by period for the test strip drum expired
in the
(see Chapter 2.3.1 and possibly the clock symbol
meter’s display)?
no
Are the test strip guide and measuring window clean?
yes
Have you observed the proper storage conditions for the
meter, test strips and control solutions (see Chapter 11 and
the package inserts that came with the test strips and control
solutions)?
yes
Has the control solution been open for less than three
months? Once opened, control solutions are only stable for
three months and must not be used after this period.
yes
138
Checking your meter
If you give the responses as specified to all these questions and the
results are still outside the stated concentration range, please call the
Accu-Chek Customer Careline free on 0800 701000 (UK) or 1800 709600
(Ireland).
If your meter has been dropped, that can also lead to implausible results
or error messages. If it has, again please call the Accu-Chek Customer
Note
If a performance check produces results that are outside the
stated concentration range, it is no longer certain that the meter
and test strips are functioning properly. Blood glucose tests may
then deliver incorrect results. Incorrect results can cause the
wrong therapeutic decision to be taken and so produce serious
Checking your meter
139
7
8
Cleaning the meter and finger pricker
8.1
Cleaning the meter
Do this as follows:
Your meter uses an optical measuring method that relies heavily on all
of its components being clean. Owing to the way the test strip works,
the meter does not normally come into direct contact with blood or
control solution. Regular cleaning is therefore largely unnecessary. In
the event of the meter becoming soiled through improper use, cleaning
it may become necessary.
Wait for the motor to stop.
Wipe away any soiling from the housing or display with a cloth lightly
moistened with cold water or 70 % ethanol.
Clean the test strip guide and measuring window thoroughly if
" the test strip guide has become visibly soiled,
8
Wipe the test strip guide with a cotton swab lightly moistened with
cold water or 70 % ethanol.
" error message E-5 is displayed (see Chapter 12.2) and the soiled
measuring window is the cause.
hand into the recess below the drum compartment cover. Then pull
the drum compartment cover with your fingers slightly to the front
and lift it up.
140
141
Notes
Use only cold water or 70 % ethanol to clean the meter. Any other
cleaning agents may damage the meter or impair its measuring
function.
Use a lightly moistened cloth or a lightly moistened cotton swab.
Do not spray anything onto the meter and do not immerse it in
the cleaning liquid. Doing so may damage the meter’s internal
components and stop it from working properly.
Make sure that no liquid enters the meter. Avoid scratching the
measuring window, as doing so could impair its measuring function.
Wipe the measuring window and the area surrounding it with a cotton swab lightly moistened with cold water or 70 % ethanol.
Remove any fluff or lint that may remain.
Allow areas you have wiped time to dry thoroughly.
Fold the drum compartment cover down and press it shut. There will
be an audible CLICK.
i
Make sure that the drum compartment cover is tightly closed. If it
is not properly closed, the meter will not turn on when you press
the Test button.
Healthcare professionals using the meter to test several patients’
blood glucose must also read the directions in Chapter 10.3
relating to disinfection.
Perform a performance check (see Chapter 7).
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143
8
9
8.2
Cleaning the finger pricker
Clean your finger pricker regularly to keep it in good working condition.
If any blood gets on it, always wipe this away immediately. Clean the
outside of the finger pricker only. Wipe it once a week with a cloth lightly
moistened with 70 % ethanol or 70 % isopropanol (available from your
pharmacist).
In addition, thoroughly wipe the inside of the cap using a cotton bud
lightly moistened with one of the two cleaning fluids.
Changing the batteries
When the battery symbol first appears in the display, the batteries are
running low. With these batteries you can perform about 50 more tests.
However, we recommend that you replace the batteries as soon as possible. By then the batteries will have been heavily drained, and changeable conditions (e.g. cold surroundings) can affect their performance
even further.
9
Notes
After cleaning, allow the finger pricker time to dry thoroughly.
Never dip the finger pricker in cleaning liquid. Doing so may
damage the internal parts of the finger pricker so affecting its
operation.
Use only 70 % ethanol or 70 % isopropanol to clean the finger
pricker. Other cleaning agents may attack the plastic and stop the
finger pricker from operating properly.
Press lightly on the battery compartment cover and slide it in the
direction of the arrow.
Lift off the cover.
Remove the used batteries.
144
145
Notes
i
A fresh pair of batteries has enough power either for about 1000
tests or for one year’s worth of tests. If you have changed the
brightness of the display to level 3 (high) or set Acoustic Mode to
on, the battery life will be shorter.
i
When you replace the batteries, your results always remain
saved.
i
The year, time and date settings only remain saved as long as
Insert two new batteries (type AAA, LR 03, AM 4 or micro).
" you do not take longer than two minutes to change the batteries,
The minus (-) ends of the batteries must match up with the minus
marks in the battery compartment.
" you do not press any button while the batteries are not
inserted,
Re-attach the battery compartment cover.
" you do not open the drum compartment while there are no
batteries inserted.
The three hooks on the underside of the cover must engage with the
slots along the edge of the battery compartment. The cover is then just
loosely held in position.
Slide the battery compartment cover back into place.
It locks with an audible CLICK.
146
" you turn the meter off before removing the batteries.
If one of the above conditions is not met you will need to re-enter
the year, time and date.
If you do not enter the year, time and date, all future results will
be displayed and saved without the time and date. In that case
147
9
the test results saved in memory will be numbered consecutively
so you can still recognize the order in which they were saved
(see Chapter 5.2).
i
Never throw batteries into a fire. This is dangerous because they
may explode.
If the year, time and date have been lost, the meter rotates the
drum in order to re-read the bar code.
i
Remove the batteries if you will not be using your meter for any
length of time. When you insert the batteries again, remember to
set the year, time and date.
You can also use rechargeable NiMH batteries. If you do, please
note the following:
i
Think of the environment. Dispose of used batteries sensibly.
" The number of tests you can perform with recharged batteries is
considerably less than with ordinary batteries.
9
" To be ready to test at any time, you need to keep two rechargeable
batteries in reserve which you can charge while the first pair are in
the meter.
" Recharged batteries lose their charge during storage.
" When the battery symbol first appears, you can perform significantly
fewer than 50 further tests. With old and exhausted rechargeable
batteries you may not be able to perform even one more test.
" The performance and useful life of rechargeable batteries depends
to a large extent on the quality of the battery charger you are using.
" Owing to the higher power consumption, we advise against using
rechargeable batteries if the brightness of the display is set to level
3 (high) or if Acoustic Mode is set to on.
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149
10
Blood glucose testing in a multi-patient setting –
Information for healthcare professionals
Only healthcare professionals are allowed to perform blood glucose
tests on more than one patient using the same Accu-Chek Compact Plus
meter.
Any patient with an infection or suffering from an infectious
disease and any patient who is a carrier of a multiresistant
organism must be assigned his/her own meter. This applies
also if a patient is suspected of being one of the above. For
as long as the suspicion exists, the meter must not be used
to test any other patient.
When using the meter always follow the recognized procedures for handling objects that are potentially contaminated with human material.
Practise the hygiene and safety policy of your laboratory or institution.
patient self-monitoring by a single person. It must not be used
to collect blood in a multi-patient setting as it does not
incorporate any features to guard against cross-infection.
Also, to stop your meter becoming contaminated, please follow the
directions printed on the next few pages.
Notes
Patients and healthcare workers are potentially at risk of becoming infected when the same Accu-Chek Compact Plus meter is
used to test blood glucose in several patients. Any object coming
into contact with human blood is a potential source of infection
(see: Clinical and Laboratory Standards Institute: Protection of
Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline – Third Edition; CLSI document M29-A3,
2005).
150
Blood glucose testing in a multi-patient setting
Healthcare professionals testing blood glucose in a multi-patient
setting must not use the Accu-Chek Softclix Plus finger pricker to
collect blood and should therefore remove the finger pricker from
the meter. The finger pricker may be replaced with a blanking
plate (see Chapter 10.1).
For healthcare professionals we recommend the Accu-Chek
Safe-T-Pro Plus or Accu-Chek Safe-T-Pro Uno disposable finger
prickers.
i
The hypo indicator level may vary from person to person. Therefore we recommend leaving the hypo indicator function turned
off when using the meter in a professional setting.
151
10
10.1 Replacing the finger pricker with a blanking plate
Undock the finger pricker from the meter as follows.
Instead of the finger pricker you can use a blanking plate which is available from the Accu-Chek Customer Careline free on 0800 701000 (UK)
or 1800 709600 (Ireland).
/
0
10
Push the slide button in the direction indicated by the arrow (1) and
hold it there.
Slide the finger pricker out in the direction indicated by the arrow
(2).
Hold the meter so it is horizontal, with the recess for docking the finger pricker pointing upwards.
Slide the blanking plate over the recess from the left along the
meter in the direction indicated by the arrow.
The guides along the inside of the recess must engage with the
grooves along the blanking plate. The blanking plate is properly
attached when it locks into place with an audible CLICK.
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153
10.2 Testing blood glucose
Correct
Wear protective gloves.
Wash or disinfect the patient’s finger and allow it to dry thoroughly.
The drop of blood does not spread so easily over dry skin.
Use only a finger pricker that is approved for use by healthcare professionals.
Use a finger pricker with adjustable penetration depth settings.
Select a penetration depth to suit the patient’s skin type. Start with a
shallow depth setting.
Drop of blood approx. 1.5 μL
Select a puncture site along the side of a fingertip.
Hold the meter with the test strip pointing downwards (see illustration).
Turn the finger so the chosen puncture site is facing upwards, and
keep it facing upwards. The drop of blood cannot then spread so
easily.
Immediately after the drop of blood has formed: Hold the tip of the
test strip against the drop of blood so the black notch is touching
the drop of blood. The test strip draws up blood.
Prick the side of the fingertip.
Move the test strip away from the drop of blood as soon as the
hourglass symbol is displayed and the meter beeps (only when
the beep tone is turned on). The test strip has then drawn up enough
blood, and test starts.
Using gentle pressure, massage the finger towards the fingertip to
encourage a drop of blood to form. A proper but nevertheless small
drop of blood (approx. 1.5 μL) must form.
When the result is displayed, hold the meter upright over a waste
bin and press the Test button to turn it off. The used test strip drops
out.
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155
10
Notes
Residues of water or disinfectant on the skin can dilute the drop
of blood and so produce false results.
Always hold the meter so the test strip is pointing downwards
when you are drawing up blood with the test strip. If you hold it
so the test strip is pointing upwards or sideways or you lay the
meter down with the test strip still in, blood can enter the meter
and contaminate it. Hold the meter with the test strip pointing
downwards until the result is displayed (measuring time approx.
5 seconds) and you have ejected the test strip.
Always turn the meter off by pressing the Test button, so as to
eject the test strip. Do not pull the test strip out. If you do pull the
used test strip out, blood can enter the meter and contaminate it.
Dispose of used lancets or disposable finger prickers and used
test strips according to local hygiene and safety regulations.
i
Wrong
Test strip pointing upwards
The test strip cannot properly draw up blood that has spread over
the skin.
Wrong
To test blood glucose you require approximately 1.5 μL of blood.
Avoid producing large drops of blood on the patient’s finger.
Where the drops of blood are too large, the meter may come into
contact with the blood. Wipe off any large drops of blood. Test
using the drop of blood that forms again at the puncture site.
10
Drop of blood
that has spread
i
If you collect blood from an earlobe, be sure that the blood is on
top and not hanging from the earlobe. Hold the earlobe or position the patient so the puncture site is on top.
Wrong
Drop of blood
too large
156
157
10.3 Disinfecting the meter
The Accu-Chek Compact Plus meter may be disinfected. Disinfection is
performed according to the degree of soiling (see “When to disinfect”).
What to disinfect
The following parts of the meter may become contaminated:
hand into the recess below the drum compartment cover. Then pull
the drum compartment cover with your fingers slightly to the front
and lift it up.
Once you have opened the drum compartment cover, you will see
beneath it the small measuring window / and have access to the
lower edge of the drum compartment cover 0.
" the area around the test strip guide
/
10
" the lower edge of the drum compartment cover
" the measuring window
0
" the housing
In order to disinfect the lower edge of the drum compartment cover and
measuring window, you need to open the drum compartment cover.
First make sure the meter is turned off.
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159
Cotton buds, wipes and cloths lightly moistened with disinfectant are all
suitable for disinfecting the meter.
When to disinfect
" Each time after you have tested a patient’s blood glucose:
wipe the area around the test strip guide.
Remove any fluff or lint that may remain.
If you find blood on the cloth, wipe also the test strip guide itself and
the measuring window.
Fold the drum compartment cover down and press until it closes. It
locks with an audible CLICK.
Ensure that the drum compartment cover is properly closed.
" If there is blood on the meter:
wipe the meter.
" If blood has entered the meter:
Notes
The test strip guide and measuring window must always be kept
clean. When you turn the meter on to perform a test, the test strip
is advanced over the measuring window and out through the test
strip guide. Any residues of blood remaining on the measuring
window or in the test strip guide may get onto the test strip and
contaminate it.
Make sure that no liquid enters the meter. Avoid scratching the
measuring window, as scratches could impair its measuring
function.
wipe the area around the test strip guide, the lower edge of the
drum compartment cover and the measuring window.
The meter, test strip guide and measuring window must be thoroughly
cleaned and disinfected at least once a day after use. Carefully check all
recesses, grooves and gaps, as well as the blanking plate.
Do not spray anything onto the meter and do not immerse it in
liquid. Doing so may damage the meter’s internal components
and stop it from working properly.
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161
10
11
10.4 Suitable disinfectants
Use only disinfectants of proven effectiveness quoted in official guidelines (e.g. Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline – Third Edition; CLSI document M29-A3, 2005).
Use alcohol-based surface disinfectants with virucidal activity. Suitable
agents are those, for instance, based on alcohols, aldehyde cleavers and
quaternary compounds*. Use them according to manufacturer’s instructions.
Measurement and storage conditions
The reliability of your meter and finger pricker as well as the accuracy of
your results is influenced by a number of factors. Pay close attention to
the following points.
A meter that has been dropped can produce false results.
11.1 Temperature range
" Without the batteries and without the test strip drum the meter
may be stored at between -25 °C and +70 °C.
" With the batteries and without the test strip drum the meter may
be stored at between -10 °C and +50 °C.
At temperatures above +50 °C the batteries could leak and
damage the meter.
11
* List of disinfection methods that have been tested in accordance with the “Richtlinien für
die Prüfung chemischer Desinfektionsmittel” [Guidelines for testing chemical disinfectants]
and the “Anforderungskatalog” [Requirements catalogue] of the DGHM (Deutsche Gesellschaft für Hygiene und Mikrobiologie e V.) [=German Society for Hygiene and Microbiology]
based on the DGHM standard methods for testing chemical disinfection methods and have
been found to be efficacious by the Desinfektionsmittel-Kommission [=Disinfectants Commission] of the DGHM in collaboration with representatives of the following professional
associations: DGKH (Deutsche Gesellschaft für Krankenhaushygiene e. V.) [=German Society for Hospital Hygiene], GHU (Gesellschaft für Hygiene und Umweltmedizin e. V.) [=German Society for Hygiene and Environmental Medicine], DVV (Deutsche Vereinigung zur
Bekämpfung der Viruskrankheiten e.V.) [=German Association for the Control of Viral Diseases] and DVG (Deutsche Veterinärmedizinische Gesellschaft e. V.) [=German Veterinary
Society]
162
At temperatures below -10 °C the batteries do not have
enough power to keep the internal clock functioning.
" With the batteries and with the test strip drum the meter may be
stored at between +2 °C and +30 °C.
" For blood glucose tests and performance checks the permitted
range is from +10 °C to +40 °C.
163
" Blood glucose tests may be performed at the limit of the permitted
range (between +6 °C and +10 °C or between +40 °C and +44 °C).
When the temperature is at the limit of the permitted range, the
thermometer symbol flashes in the display.
Do not use results obtained at the limits of the permitted
temperature range as a basis for making therapeutic decisions. The results may be incorrect. Incorrect results can
cause the wrong therapeutic decision to be taken and so produce serious adverse health effects.
" Tests cannot be performed at temperatures below +6 °C and above
+44 °C.
In this event the following message is displayed:
Never try to speed up warming or cooling of your meter, e.g. by
placing it on a radiator or in a refrigerator. Doing so can damage
the meter and cause it to give incorrect results. Incorrect results
can cause the wrong therapeutic decision to be taken and so
produce serious adverse health effects.
Keep the finger pricker without a lancet inserted.
Never expose the finger pricker to high temperatures (e.g. in a
hot car). High temperatures can cause parts of the finger pricker
to become warped, so impairing its operation.
11.2 Light conditions
All displayed numbers and symbols appear yellow. Bright light shining
on the display may make them difficult to read. Shield the meter if necessary using your body, for instance.
" Keep the finger pricker at temperatures between -25 °C and
+70 °C.
164
Keep the meter away from very strong light sources (e.g. direct
sunlight, studio lighting, spot lights, etc.). These may interfere
with the proper functioning of the meter and cause error messages to be displayed.
165
11
12
11.3 Humidity
Only test blood glucose at a relative humidity of between 20 % and
85 %.
Keep the meter and finger pricker at a relative humidity of between
20 % and 85 %.
Sudden changes in temperature cause condensation to form in or
on the meter. If this happens, do not turn the meter on. Make
sure that it returns to ambient temperature slowly. Never keep it
in a room that is likely to harbour condensation (e.g. a bathroom).
Symbols, error messages and troubleshooting
In addition to test results, the time and the date, your meter also displays other symbols and error messages. Some of these routine display
messages have already been explained in earlier chapters. Following is
a complete summary of all symbols and messages, what they mean and
what actions you should take when they appear.
When you use your meter, please watch out for any symbols and error
messages that are displayed. They provide you with important information. If you do not recognize a symbol or do not understand an error
message, please refer immediately to this chapter for an explanation.
Otherwise you run the risk of wrongly interpreting your results.
On some of the pages that follow you will see a double arrow . It signifies the following:
11.4 Local sources of interference
Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use the meter in close to sources of
strong electromagnetic radiation.
" when it appears on the right at the bottom of the page – the
description continues on the next page
" when it appears on the left at the top of the page – this is the continuation of the description from the last page
To avoid electrostatic discharge, do not use the meter in a very
dry environment, especially one in which synthetic materials are
present.
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167
12
12.1 Symbols shown in the display
Symbols may be displayed singly or several at once. When several symbols are displayed, each symbol can have its own meaning. Alternatively, the combination of symbols may mean something.
1
13
2
12
11
10
9
In the following example you see a display with several symbols. This
display appears when you have turned on the meter to perform a blood
glucose test.
3
4
5
8
7 6
Here each symbol has its own meaning. The symbols shown along with
the time and date mean:
17
16
14
You can draw up blood or control solution with the test strip
now.
18
You inserted a partly used test strip drum.
15
5
168
The beep tone or Acoustic Mode is set to on.
169
12
In the tables presented below you will first see the meanings of symbols
that appear singly or have the same meaning when they appear
together with other symbols. These are followed by the meanings of
combinations of symbols and of symbols that appear in the numeric
field.
12.1.1 Single symbols
Symbol
Meaning
1
Draw up blood or control solution with the
test strip now.
2
During a test and when the result is being
displayed: the temperature is outside the
permitted range of +10 °C to +40 °C.
Do not use this result as a basis for therapeutic decisions.
Move to a place where the temperature is
between +10 °C and +40 °C and wait for
the temperature of the meter to adjust to
this temperature. Repeat the test with a
new test strip.
170
Symbol
3
Meaning
In memory: at the time of testing the temperature was outside the permitted range.
When the symbol first appears in the display, you can perform about 50 more
tests.
If you use NiMH rechargeable batteries
instead of normal batteries, fewer than 50
more tests can be performed. If the
rechargeable batteries are old and
exhausted, it may not be possible to perform even one more test.
When the batteries are so low that no
more tests can be performed, just the battery symbol appears briefly for 3 seconds
in the display. Then the meter turns off.
Insert two batteries (new or recharged).
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12
Symbol
Meaning
4
See under Combinations of symbols
5
The unit your meter uses to display the
blood glucose result, either mmol/L or
mg/dL (depending on the meter).
6
The meter cannot calculate the use-by
period for this test strip drum
Symbol
Meaning
Only in a new meter that has not yet been
used to perform tests: There is no test
strip drum in the meter or the mock drum
has been left inserted. Insert a new test
strip drum (see Chapter 2.3).
7
This result is a performance check result.
See under Combinations of symbols
" because you inserted a partly used
test strip drum,
" because you opened the drum compartment cover,
" because the year, time and date settings were lost when you changed the
batteries and at this time the drum
was partly used (see Chapter 9).
172
8
After testing: You have turned on the hypo
indicator and the displayed result is below
the level you set.
12
You are in the hypo indicator setting.
In memory: The result is below the limit
that was set at the time of testing.
173
Symbol
9
Meaning
You are in the settings.
10
Flag for a special result, e.g. obtained
from alternative site testing
11
You have turned on at least one alarm or
you are in the alarm clock setting.
Optical warning while the alarm sounds
for 20 seconds.
12
The beep tone (H) or Acoustic Mode
(H) is set to on.
13
The test strip has drawn up enough blood
or control solution, and test is running.
14
When an average is displayed (from memory): the symbol is preceded by the number of days covered.
174
Symbol
15
Meaning
You are in memory. Either the saved result
or one of the averages, highest or lowest
results is being displayed.
During averaging, when the calculation is
taking a while.
16
Displayed additionally when 12-hour time
format is selected.
17
When an average is displayed (from memory): the symbol is followed by the number
of tests n included in the calculation.
12
175
12.1.2 Combinations of symbols
Symbols
Meaning
The following combinations of symbols have meanings of their own.
In memory: The test strip you used for this
test was unusable (the 90-day use-by
period had expired, see Chapter 2.3.1).
Symbols
Meaning
4+6+7
The 90-day use-by period for the test strip
drum has expired (see Chapter 2.3.1). The
test strips cannot be used.
The result in memory may be
incorrect. Incorrect results can
cause the wrong therapeutic decision to be taken and so produce
serious adverse health effects.
You must not use these test strips,
as they may produce incorrect
results. Incorrect results can cause
the wrong therapeutic decision to
be taken and so produce serious
4+6
See symbol combination 4 + 6 + 7
After the symbol combination 4 + 6 + 7
appeared, you performed a performance
check, so the bottle symbol is no longer
displayed.
6+7
The meter is unable to calculate the useby period for the test strip drum and is
prompting you to perform a performance
check,
" because you have just changed the
batteries, the year, time and date settings have been lost (see Chapter 9)
and, at the same time, a partly used
drum remains in the meter,
176
177
12
Symbols
Meaning
12.1.3 Symbols appearing in the numeric field
" because you have just inserted a
partly used test strip drum,
In the numeric field: (mmol/L meter) or (mg/dL meter) the
following symbols may appear:
" because you have just opened the
drum compartment cover.
Perform a performance check (see Chapter 7). If the test produces a correct result,
you may continue to use the test strips. If
the result is incorrect, you need to insert a
new drum. Following the performance
check, the bottle symbol disappears from
the display. The drum symbol continues to
be displayed in order to draw your attention to the fact that the meter cannot calculate the use-by period. The symbol only
disappears when you insert a new test
strip drum. All results are saved along with
the drum symbol. If you do not perform a
performance check, the flashing bottle
symbol appears with every test until you
insert a new drum.
178
Symbol
18
Meaning
In memory:
" No results present in memory.
" Averaging is not possible because
you have not set the time and date,
memory only contains results without a time and date,
memory only contains results that
are not included in the calculation,
e.g. performance results,
no results were saved in the period
in question, e.g. all results in memory are more than 7 days old,
179
12
Symbol
Meaning
the date that it is set is in the past,
you changed the time and date,
then performed a test and afterwards re-set the time and date, but
have not performed any more tests
since then.
The result is lower than 0.6 mmol/L
(10 mg/dL).
The result is greater than 33.3 mmol/L
(600 mg/dL).
You have turned the meter on in order to
download the results.
The meter is downloading results.
12.2 Interferences and error messages – causes and troubleshooting recommendations
If you receive frequent error messages, please contact the Accu-Chek
Customer Careline free on 0800 701000 (UK) or 1800 709600 (Ireland).
If this happens …
it means:
The meter will not turn
on.
" The batteries (normal or rechargeable)
are empty or none are inserted.
Insert batteries (new or recharged).
" You inserted the batteries the wrong
way round.
Remove the batteries and re-insert
them as shown in the battery compartment. If the batteries were in the
meter the wrong way round for longer
than two minutes, the year, time and
date are now lost. Re-enter them (see
Chapter 3).
Decimal point displayed by mmol/L
meters and is part of the result (e.g. 8.2
mmol/L is displayed as )
180
181
12
If this happens …
it means:
If this happens …
it means:
" The drum compartment cover is not
properly closed.
The meter is turned on,
but the display is blank.
The display is defective.
Close the drum compartment cover. It
must close with an audible CLICK.
" The ambient temperature is low and
the batteries are almost empty.
Move to a place where the temperature is between +10 °C and +40 °C
and wait for the temperature of the
meter to adjust to this temperature.
Insert batteries (new or recharged).
" Condensation has affected the electronics.
Allow the meter to dry slowly.
" The meter is defective.
Please contact the Accu-Chek Customer Careline free on 0800 701000
(UK) or 1800 709600 (Ireland).
Please contact the Accu-Chek Customer
Careline free on 0800 701000 (UK) or
1800 709600 (Ireland).
The clock has stopped or The meter was exposed to a temperature
the clock is slow.
below –10 °C and the batteries are beginning to freeze.
Turn the meter off. Move to a place where
the temperature is between +10 °C and
+40 °C and wait for the temperature of
the meter to adjust to this temperature.
When the meter is turned " The meter was exposed to a temperature below –10 °C and the batteries
on, the date is shown as
are beginning to freeze.
0-00 and the time is
shown as 0:00.
Press the Test button to turn the meter
off. Move to a place where the temperature is between +10 °C and
+40 °C and wait for the temperature
of the meter to adjust to this temperature.
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183
12
Error message
Meaning
Error message
" The year, time and date have not been
set.
Set these as described in Chapter 3.
The test strip drum in the meter is empty.
Meaning
Perform a performance check. You
may use up all the test strips remaining in the drum. The 90-day use-by
period will no longer be calculated for
this drum. The drum symbol will
therefore be displayed each time you
perform a test until you insert a new
test strip drum.
" The bar code on the test strip drum is
damaged.
" The bar code information from the test
strip drum has been lost.
off. Open and close the drum compartment cover. The meter rotates the
drum and reads the bar code. When
you next turn on the meter to perform
a test, the drum symbol and flashing
bottle symbol are displayed.
You can no longer perform tests with
test strips from this drum. Insert a
new drum.
" The test strip drum does not rotate.
off. Open the drum compartment
cover and press the red drum release
button. Close the drum compartment
cover again.
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185
12
Error message
Meaning
The meter rotates the drum and reads
the bar code. When you next turn on
the meter to perform a test, the drum
symbol and flashing bottle symbol are
displayed. Perform a performance
check. You may use all the test strips
remaining in the drum. The 90-day
use-by period will no longer be calculated for this drum. The drum symbol
will therefore be displayed each time
you perform a test until you insert a
new test strip drum.
damaged.
new drum.
Error message
Meaning
" The measuring window is dirty.
off. Clean the measuring window (see
Chapter 8.1) and repeat the test with a
new test strip.
" A test strip is stuck in the meter.
Hold the meter upright so the test strip
is pointing downwards. Press the Test
button to turn the meter off and allow
the test strip to drop out. If the test
strip does not drop out, remove it
manually, even if you feel some resistance.
" The test strip drew up too little blood
or control solution.
Turn the meter off and then on again
by pressing the Test button. Repeat
the test with a new test strip and a
larger amount of blood or control solution.
186
187
12
Error message
Meaning
Error message
Meaning
" You drew up blood or control solution
too soon with the test strip, i.e. before
the test strip symbol and drop symbol
were flashing in the display.
" The test strip that was advanced is
defective.
the test with a new test strip. Only
draw up blood or control solution with
the test strip when the test strip symbol and drop symbol are flashing in
the display.
" You bent or moved the test strip during
the test either while you were drawing
up blood or control solution with it or
during the test.
the test with a new test strip.
188
Hold the meter upright so the test strip
is pointing downwards. Press the Test
button to turn the meter off and allow
the test strip to drop out. Press the
Test button to turn the meter on again
and repeat the test.
" You pulled the test strip out of the
meter.
off. Only remove the test strip from the
meter by pressing the Test button to
turn the meter off.
" There is condensation in the meter.
off. Leave it to dry at room temperature.
189
12
Error message
Meaning
Error message
" The batteries (regular or rechargeable)
are empty or a meter error has
occurred.
by pressing the Test button. If the error
message appears again, the batteries
may be empty. Insert new batteries
(new or recharged). If the error message is again repeated when the
meter turns on, please contact the
Accu-Chek Customer Careline free on
0800 701000 (UK) or 1800 709600
(Ireland).
" The meter was exposed to a strong
electromagnetic field.
off. Move somewhere else or turn off
the source of the field.
" You bent or moved the test strip during
the test either while you were drawing
up blood or control solution with it or
during the test.
Meaning
the test with a new test strip.
" You drew up blood or control solution
too soon with the test strip, i.e. before
the test strip symbol and drop symbol
were flashing in the display.
the test with a new test strip. Only
draw up blood or control solution with
the test strip when the test strip symbol and drop symbol are flashing in
the display.
You pulled the test strip out of the meter
during testing.
Turn the meter off and then on again by
pressing the Test button. Repeat the test
with a new test strip. Only remove the test
strip from the meter by pressing the Test
button to turn the meter off.
190
191
12
Error message
192
Meaning
Error message
Meaning
The test strip is stuck or the test strip
drum does not rotate.
" The meter has been exposed to severe
differences in temperature.
Open the drum compartment cover and (if
applicable) pull out the test strip. Press the
red drum release button and remove the
test strip drum. Insert the test strip drum
again and close the drum compartment
cover. The meter rotates the drum and
reads the bar code. When you next turn on
the meter to perform a test, the drum
symbol and flashing bottle symbol are displayed. Perform a performance check. You
may use all the test strips remaining in
the drum. The 90-day use-by period will
no longer be calculated for this drum. The
drum symbol will therefore be displayed
each time you perform a test until you
insert a new test strip drum.
" The ambient temperature or the temperature within the meter is too low
(below +6 °C) or too high (above
+44 °C) for a test.
Move to a place where the temperature is
between +10 °C and +40 °C and wait for
the temperature of the meter to adjust to
this temperature.
The test strip drew up too little blood or
control solution.
pressing the Test button. Repeat the test
with a new test strip and a larger amount
of blood or control solution.
193
12
Error message
Meaning
" There is no test strip drum in the
meter.
off. Insert a new test strip drum (see
Chapter 2.3).
damaged.
new drum.
" You inserted a test strip drum from a
different blood glucose measuring
system.
Error message
Meaning
In memory: the result in memory cannot
be displayed.
All other results in memory can continue
to be retrieved with the M or S button.
A meter error has occurred.
pressing the Test button. If the error message persists, please contact the
Accu-Chek Customer Careline free on
0800 701000 (UK) or 1800 709600
(Ireland).
off. Insert an Accu-Chek Compact test
strip drum (see Chapter 2.3).
194
12
195
13
Technical data
Meter type
Accu-Chek Compact Plus (Model GT)
Measuring time
Catalogue No./
Serial No.
See type plate on the back of the meter
System operating
temperature
Test principle
Determination of glucose in fresh capillary
blood by reflectance photometry. When using
different specimen material please refer to
the package insert that came with the
Accu-Chek Compact test strips.
Blood glucose concentrations may be measured in whole blood or in plasma. Although
you always draw up whole blood with the test
strip, your meter displays blood glucose
results that relate either to whole blood or to
plasma. To see whether your blood glucose
meter displays results relating to whole blood
or to plasma, please read the package insert
that came with your test strips. There you will
also find information on how the system
works, on the test principle and on reference
methods.
Measuring range
0.6–33.3 mmol/L (10–600 mg/dL)
Sample size
approx. 1.5 μL (1 μL (microlitre) =
1 thousandth of a millilitre)
196
Technical data
Storage temperature
Meter
approx. 5 seconds (depending on concentration)
+10 °C to +40 °C
without batteries and
without a test strip drum: -25 °C to +70 °C
with batteries and
without a test strip drum: -10 °C to +50 °C
with batteries and
with a test strip drum: +2 °C to +30 °C
Finger pricker
-25 °C to +70 °C
Humidity
during testing
20 % to 85 % relative humidity
during storage
20 % to 85 % relative humidity
Altitude
Sea level to 4000 m
Memory
500 results together with time and date, averages, highest and lowest value for 7, 14 and
30 days
Dimensions
without finger pricker
121 × 57 × 32 mm
with finger pricker
125 × 64 × 32 mm
Technical data
197
13
Weight
approx. 147 g with finger pricker, batteries
and test strip drum
Display window
OLED (Organic Light Emitting Diode) display
Automatic power-off
after 60 seconds or 5 minutes depending on
operating status
Power supply
2 batteries (type AAA, LR 03, AM 4 or Micro)
or 2 NiMH rechargeable batteries (type AAA)
Battery life
approx. 1000 results or approx. 1 year (less
when the brightness of the display is set to
level 3 (high), or in Acoustic Mode owing to
the higher power consumption, or when
rechargeable batteries are used)
Interface
Infrared interface
Safety class
III
LED/IRED
Class 1
Electromagnetic
compatibility
This device meets the electromagnetic immunity requirements according to EN ISO 15197
Annex A. The chosen basis for the immunity
tests (on electrostatic discharge) was basic
standard IEC 61000-4-2.
In addition it meets the electromagnetic
emissions requirements according to EN
61326. Its electromagnetic emission is thus
low. Interference from other electrically powered equipment is not to be anticipated.
Performance evaluation The performance data for the Accu-Chek
Compact Plus system (Accu-Chek Compact
Plus meter together with Accu-Chek Compact
test strips) were determined using capillary
blood from patients with diabetes (method
comparison, accuracy), venous blood (repeatability) and control solutions (reproducibility).
The system is calibrated with venous blood
containing various levels of glucose. The reference values are obtained using the hexokinase method. The method comparison was
conducted by comparing the results from the
system with those of the hexokinase method
with deproteination using an automatic analyzer. The hexokinase method is traceable to
an NIST standard (traceability).
The Accu-Chek Compact Plus system complies with the requirements of
EN ISO 15197.
198
Technical data
Technical data
199
13
14
Disposing of the meter
15
System components
During blood glucose testing the meter itself may come into contact
with blood. Used meters therefore carry a risk of infection. Please dispose of your used meter - after removing the batteries - according to
the regulations applicable in your country. For information about correct
disposal please contact your local council or authority.
Use only Accu-Chek Compact test strips for testing with the Accu-Chek
Compact Plus meter. These are available from your pharmacist.
The meter falls outside the scope of the European Directive 2002/96/EC
(Directive on waste electrical and electronic equipment).
Only use Accu-Chek Softclix lancets in your Accu-Chek Softclix Plus finger pricker. The lancets are available in various pack sizes.
Use only Accu-Chek Compact Autocontrol control solutions to perform
performance checks on your Accu-Chek Compact Plus meter.
If you wish to use blood from alternative sites (such as the base of the
thumb, forearm, upper arm, calf or thigh), you need a special, transparent AST cap to obtain blood using the Accu-Chek Softclix Plus finger
pricker. It is available through the Accu-Chek Customer Careline free on
0800 701000 (UK) or 1800 709600 (Ireland).
For healthcare professionals we recommend the Accu-Chek Safe-T-Pro
Plus or Accu-Chek Safe-T-Pro Uno disposable finger prickers.
14
15
200
Disposing of the meter
System components
201
16
17
Patents
Accu-Chek Compact Plus Meter
EP 732 590; EP 738 666; EP 742 436; EP 1 189 064; US 5,463,467;
US 5,720,924; US 5,863,800; US 6,707,554; US 6,475,436;
WO 2004/003549
Accu-Chek Softclix Plus Finger pricker
US 4,924,879; US-2004-0092996; US 2005-00908580; US Re. 35,803
16
Patent information
Roche has been granted patent protection in the USA for the Accu-Chek
Softclix Plus finger pricker and its use in combination with Accu-Chek
Softclix and Accu-Chek Softclix XL lancets (US Patents 4,924,879 and
Re. 35,803). Similar patent protection also exists in other countries,
especially through European Patents 0565970, 0782838 and Japanese
Patent 2702374. Your purchase entitles you to use your Accu-Chek Softclix Plus finger pricker in combination with Accu-Chek Softclix and
Accu-Chek Softclix XL lancets. As required by statute, Roche will refrain
from pursuing its patent rights against private persons using the
Accu-Chek Softclix Plus finger pricker in combination with lancets from
other manufacturers for non-commercial purposes. Acquisition of the
Accu-Chek Softclix Plus finger pricker is not associated, other than
through the aforementioned statutory limitation on the effect of the patent, with any entitlement and in particular with any tacit permission for
the acquirer to use third-party lancets. Roche reserves the right to
assert its patent rights against any manufacturer offering lancets for the
Accu-Chek Softclix Plus finger pricker.
Local customer support and service
17.1 Advice and troubleshooting
If you need advice on how to operate the Accu-Chek Compact Plus
meter or the Accu-Chek Softclix Plus finger pricker, if you seem to be
obtaining implausible results, or if you suspect that the meter, test
strips, finger pricker or lancets might be defective, please contact the
Accu-Chek Customer Careline free on 0800 701000 (UK) or 1800
709600 (Ireland). Do not attempt to repair or modify the meter or finger
pricker yourself. When you call, our staff will help you solve any problems you might be experiencing with the meter, test strips, finger
pricker or lancets from Roche Diagnostics. See the next section for contact details.
17
202
Patents
203
18
17.2 Addresses
Alphabetical index
A
Acoustic Mode 120
setting 45
Alarm clock function
beep tone 59
setting alarms 59
symbol 60, 174
turning off individual alarms
65
Alternative sites 70, 201
AST cap 70, 201
Asterisk symbol 96, 174
At a glance
finger pricker 15
meter 12
symbols 167
average (symbol) 108, 174
Averages 107
Accu-Chek Customer Careline:
Freephone UK: 0800 701000
Freephone Rep. of Ireland: 1 800 709600
Roche Diagnostics Limited
Charles Avenue, Burgess Hill
West Sussex, RH15 9RY
United Kingdom
Web: www.accu-chek.co.uk
B
Bar code 16
Batteries
changing 145
disposal of ~ 149
life 147, 198
symbol 145, 171
types 14, 146, 198
204
Alphabetical index
Batteries, rechargeable 148
Battery compartment 14
Battery compartment cover 14
Beep tone
alarm clock function 59
announcement of results
using ~ 123, 126
during testing 45, 123
in Acoustic Mode 121
pitch 46, 121
setting 45
symbol 44, 174
Bell symbol 60, 174
Blanking plate 152
Blood
drawing up with test strip
84
obtaining 80
too little drawn up 89
volume 17, 196
Bottle symbol 35, 134, 173, 176
Brightness, display 48
C
Causes of error
downloading of results 118
performance check 137
test 99
205
18
Checking, meter 129
Cleaning
finger pricker 144
meter 140
Clock symbol 33, 176
Control solution 129
concentration table 130,
135
disposal of ~ 137
drawing up with test strip
133
use-by date 138
Control window, test strip drum
14, 28
Customer support and service
203
D
Data downloading 114
day (symbol) 108, 174
Disinfectants 162
Disinfecting, meter 158
Display 12
illustrations 19, 169
number of strips remaining
36
setting the brightness 48
symbols in the ~ 168
206
Display check 21, 44, 78, 102
Disposal
batteries 149
control solution 137
lancet 94
meter 200
test strip drum 32
test strips 91
Downloading, results 114
causes of error 118
Drop symbol 84, 170
Drum compartment 12
Drum compartment cover 12
Drum release button 12, 25
Drum symbol 172, 176
E
E and number (symbol) 184
EEE (symbol) 195
Electromagnetic compatibility
198
End (symbol) 29, 184
Error messages 181
in Acoustic Mode 128
F
Flagging, result 96
Finger pricker
at a glance 15
cleaning 144
docking 74
obtaining blood using the ~
80
priming 81
replacing with a blanking
plate 152
undocking 73
H
HI (symbol) 98, 180
Highest value 107
Hourglass symbol 86, 174
Humidity 166, 197
Hypo indicator
setting 67
symbol 67, 173
hypo? (symbol) 67, 173
I
Intended use
finger pricker 5
meter 4
L
Lancet 15
disposal of ~ 94
ejecting 92
inserting 75
Light conditions 165
Light source, interfering 165
Liquids for cleaning
finger pricker 144
meter 140
LO (symbol) 98, 180
Lowest value 107
M
M button 12, 42, 102
Measurement conditions 163
Measuring range 98, 196
Measuring time 86, 197
Measuring window 12
mem (symbol) 102, 175
Infection risk 4, 150
Infrared window 14, 115
Alphabetical index
Alphabetical index
207
18
Memory 101, 197
Memory location number 101,
106
Memory, results 101
Meter
at a glance 12
checking 129
cleaning 140
disinfecting 158
disposal of ~ 200
storage 163
turning off 43, 90, 105
turning on 44, 78, 102
mg/dL (symbol) 20, 172
mmol/L (symbol) 20, 172
Penetration depth setting 15
window 15, 80
Plunger, finger pricker 15, 71
Problems 181
R
N
Release button
finger pricker 14, 73
test strip drum 12, 25
Result
average 107
downloading to e.g. a PC
114
flagging 96
highest value 107
lowest value 107
retrieving from memory 102
n (symbol) 108, 175
NiMH batteries 148
S
P
Patents 202
Performance check 129
causes of error 137
Performance evaluation 199
Penetration depth 80
setting 81
208
S button 12, 42, 103
set (symbol) 41, 174
Settings 38
Acoustic Mode 45
alarm clock function 59
beep tone 45
brightness of the display 48
changing, rules 41
closing 43
Alphabetical index
date 56
factory defaults 39
following battery replacement
39, 40, 147
hypo indicator 67
order 41
time 54
time-and-date format 52
turning the meter on 44
year 50
Setting the date 56
Setting the time 54
Setting the time-and-date format
52
Setting the year 50
Sources of electromagnetic interference 166
Sources of interference
electromagnetic ~ 166
light 165
Storage conditions 163
Symbols 167
during testing 95
System components 201
Alphabetical index
T
Technical data 196
Temperature 163, 197
Test button 12
Test principle 196
Test strip guide 12
Test strip drum 12
disposal of ~ 32
inserting or replacing 24
partly used ~ 31
use-by period 33
Test strips 12
disposal of ~ 91
ejecting 90
indication of the number
remaining 36
symbol 84, 170
use-by date 29
Testing
causes of error 99
healthcare professionals
150
procedure 78
Thermometer symbol 164, 170
209
18
Troubleshooting 181
Turning off, meter
after testing 90
automatic ~ 23, 43, 88, 91,
106, 117, 198
closing settings 43
exiting memory 105
Turning on, meter
retrieving results 102
settings 42, 44
testing 78
Type plate 14
U
Unit of measurement (mmol/L
and mg/dL) 20
Use-by date
control solution 138
test strips 29
Use-by period, test strip drum 33
cannot be calculated 34
expired 33
210
Alphabetical index
0088
ACCU-CHEK and SOFTCLIX
are trademarks of Roche.
Distributed by:
Roche Diagnostics Limited
Charles Avenue, Burgess Hill
West Sussex, RH15 9RY
www.accu-chek.co.uk
UK Freephone number: 0800 701 000
ROI Freephone number: 1 800 709 600
Roche Diagnostics GmbH
68298 Mannheim, Germany
www.accu-chek.com
0 5049547001(02) 2008-07
©2007 Roche Diagnostics. All rights reserved.

The new Accu-Chek Compact Plus

Transcription

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